New drug may help MS patients walk

A new drug may make getting around easier for the 2.5 million people worldwide afflicted with multiple sclerosis. It is the first medication to specifically target walking challenges faced by MS patients.

In January, the U.S. Food and Drug Administration approved Ampyra (dalfampridine) as an oral medication to improve walking in people with MS. It has been available by prescription since March 1.

The drug holds promise for Chris Messina, who misses strolling around the Staten Island Mall, and Danielle Mino, who can’t always keep up with her two young children.

Both Great Kills women have MS, a chronic disease that affects the central nervous system and can make walking a daunting experience.

Since April 21, Mrs. Messina has been taking one 10-milligram tablet of Ampyra twice a day. She’s been told it may take up to three months to experience results.

“I wait for a difference every day,” said Mrs. Messina, a 54-year-old former radiology clerk at Staten Island University Hospital.

Diagnosed in 1975, her ability to walk deteriorated about eight years ago during a relapse from which she never regained her former mobility.

“When I walk, I stumble, I trip, I walk crazy. I go back and forth and swagger,” said Mrs. Messina. “I used to live at the mall, but since I’ve been like this I haven’t been there in years.”

In two clinical trials of 540 MS patients in the United States and Canada, those treated with Ampyra had faster walking speeds on timed 25-foot walks than those given a placebo, according to Acorda Therapeutics, Inc., the Hawthorne, New York-based developer of the drug. Those whose walking speed improved, also noted an improvement in leg strength.

While the measuring stick for improvement may seem small, to those who live with MS, the trial’s findings are huge.

“My leg kind of drags a little, I don’t really have too much balance or strength especially in my right leg,” said Mrs. Mino, a 40-year-old mother of a 5½-year-old daughter and 4-year-old son.

“On a good day I can get up, get my children ready for school and then do what I have to do, cleaning, food shopping,” she explained. “But on a bad day, I just get my kids ready for school, put them on the school bus and then I just sit down most of the day.”

Ampyra is taken with other MS drugs and does not keep MS from getting worse. There is no cure for MS.

Both Mrs. Messina and Mrs. Mino are infused with Tysabri — a disease modifying medication that helps prevent relapses of MS symptoms — every four weeks at the MS Center of Staten Island in New Dorp.

“Ampyra is a symptomatic medicine. It makes you walk better, move better, but it doesn’t affect the disease itself,” said Dr. Allan Perel, director of the MS Center.

“You can still have attacks with it. You could still have progressive neurological findings. The MRIs could look worse.”

So far, more than 2,000 U.S. physicians have written at least one prescription for Ampyra, said Jeff Macdonald, a spokesman for Acorda. The MS Center has about 100 patients who have been prescribed the new drug, said Perel.

Ampyra is a potassium channel blocker which is believed to improve the transmission of nerve signals in nerve fibers whose insulating coating has been damaged by MS.

The tablets work as a timed-release formulation of dalfampridine, which was originally used as a seizure-inducing bird-control repellent.

For more than two decades, dalfampridine has been compounded in pharmacies and used off-label to treat people with various neurologic conditions.

While the FDA approved the use of Ampyra for people with any type of MS, it should not be taken by individuals with a history of seizures, or by those with moderate to severe kidney problems.

According to the FDA, when Ampyra is given at doses greater than 10 milligrams twice a day, it can cause seizures. The most common side effects reported by patients taking Ampyra in clinical trials included urinary tract infections, insomnia, dizziness, headache, nausea, back pain and balance problems.

The price of Ampyra is $1,056 for a 30-day supply (two tablets per day). It is only available by mail order through a network of specialty pharmacies that work with Acorda.

The drug’s hefty price is being offset by Acorda, which has developed assistance programs to help MS patients afford the drug.

Mrs. Mino is currently waiting for her prescription of Ampyra to arrive. Diagnosed with MS in 1999, she hopes the drug will make it easier to do activities like going on vacation with her children.

During a November trip to Disney World, trekking between attractions was especially challenging for her.

“It was so hard trying to walk through the park. At least every 10 minutes I would have to stop,” said Mrs. Mino. “Whenever we had to wait on a line for a ride, I was happy because I didn’t have to do any more walking.”

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New drug once used as bird poison shows promise for Multiple Sclerosis

An FDA panel is looking into the possibility that a new drug named Ampriva is helping people with Multiple Sclerosis. The drug is a reconfigured form of fampridine, which was originally used as a bird poison.

The Food and Drug Administration is looking at reports that the medication has helped people with MS actually walk with the help of the drug.

It's possible that the FDA will put this on the fast track because of the positive reports.

The new drug is different because it improves the nervous system function in people suffering from MS, and right now, the best that MS drugs can do is keep the progression of the disease from getting worse, and not change the already damaged nerves.

Ampriva is supposed to help protect the myelin which is damaged in people with MS. That damage is what affects movement and walking in some people with the disease.

So far, more than one-third of the people taking the new drug have been able to walk faster.

Dr. Andrew D. Goodman, director of the Multiple Sclerosis Center at the University of Rochester and the lead investigator in the clinical studies, said that "this can mean things like getting to the bathroom on time before having an accident, or getting across the street before the light changes."

Despite the obvious improvements, however, MS patients continue to get worse over time, Goodman's research shows. The results are slight at the moment.

Dr. Goodman says, "Things that people have described to me are, 'Look, I can get around the supermarket without having to hold on to the cart all the time,' or 'Just getting up that step between the garage and the house gives me independence.' "

The bird poision has been known to cause seizures and convulsions at high dosages.

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Acorda’s MS Drug May Need More Study

Acorda Therapeutics Inc.’s famprdine- SR, the first pill to improve walking in multiple sclerosis patients, may not be “clinically meaningful,” U.S. regulators said. The shares fell the most ever in Nasdaq trading.

Food and Drug Administration reviewers said they had doubts about the trial design for the drug, fampridine-SR, in a report posted today on the agency’s Web site. An FDA advisory panel will meet Oct. 14 in Adelphi, Maryland, to discuss whether the drug works well enough to justify an increased risk of seizures.

Fampridine, designed to restore nerve signals, was tested in 25-foot timed walks, a novel way to measure effectiveness. Older drugs are injected to reduce relapses and slow progression of the disease. MS damages the brain and spinal cord, affecting mobility, according to the National Institutes of Health.

The improvement patients saw with fampridine “was numerically quite small, and the average time to complete the 25-foot walk was not different between the treatment groups in either study,” said Eric Bastings, deputy director of the FDA’s Division of Neurology Products, in a memo to the panel. “For these reasons, it appears that the clinical meaning of the differences seen on the primary outcomes is in question.”

Shares Fall

Acorda, of Hawthorne, New York, dropped $4.76, or 21 percent, to $17.52 at 4 p.m. New York time in Nasdaq Stock Market composite trading. It was the biggest percentage decline since the drugmaker’s initial public offering in February 2006.

“Fampridine’s panel on Wednesday is going to be somewhat more contentious than we had anticipated,” said Phil Nadeau, a Cowen & Co. analyst in New York, in a note to clients today. “It would seem from the documents that the FDA may be moving the goal posts on Acorda” with new hurdles for proving the drug works, he said.

Acorda spokesman Jeff Macdonald declined to comment on the FDA report in a telephone interview today. The company will comment after the Oct. 14 FDA panel meeting, he said.

“How relevant is walking speed to MS?” said Mike King, an analyst for Merriman Curhan Ford & Co., in a telephone interview. “It’s risk versus benefit for the FDA, and this is a small benefit in a minority of patients, and a real risk of seizure. How do you balance those questions?”

Acorda is racing European drugmakers Merck KGaA and Novartis AG to introduce the first pill for MS. Current treatments, led by Teva Pharmaceutical Industries Ltd.’s Copaxone and Biogen Idec Inc.’s Avonex, are shots that reduce relapses and prevent symptoms of the disease from getting worse.

Damage to Myelin

MS strikes more than 2.5 million people worldwide and is caused by damage to myelin, the protective sheath around nerve cells in the brain and spinal cord, according to the National Multiple Sclerosis Society. MS worsens as damage to myelin causes muscle weakness, trouble with coordination and critical thinking, and memory loss. Women are at least twice as likely as men to get the disease.

“There might be someone using a walker or cane who finds it difficult to get from the kitchen to the bedroom, and fampridine could make it easier,” said Howard Weiner, director of the Partners Multiple Sclerosis Center at Brigham & Women’s Hospital in Boston, in a phone interview before the FDA documents were released.

A timed walking test is a logical way to measure the effectiveness of fampridine because there is a “physiologic” connection between the walking ability and the progression of the disease, Weiner said.

Priority Review

The FDA said on May 6 it would review fampridine under an expedited “priority review” program to speed clearance of novel medicines for serious illnesses. A drug awarded priority review is supposed to be decided on within six months, four months quicker than the review process for most medicines. Acorda in May said it anticipated an approval decision from the agency by Oct. 22.

Ron Cohen, Acorda’s founder and chief executive officer, said he didn’t ask for a quick review of fampridine. Transparency is critical for investors in the unprofitable biotech company, and Cohen said he was worried the application might get held up if it was taken out of normal review channels.

“To the extent that there are delays, or there are uncertainties in the process, that’s not a good thing because the last thing an investor wants to see is uncertainty,” Cohen said in an Aug. 18 phone interview.

Decades of Development

Development of fampridine was started by Dublin-based Elan Corp. in the 1990s and later licensed by Acorda. The drug is a sustained-release form of 4-aminopyridine, which some MS patients now get from compounding pharmacies with a doctor’s prescription. These medicines are custom made for patients and overdoses can cause seizures and other side effects.

Fampridine helped 35 percent of MS patients walk faster in a study whose results were reported in February. The drug’s ability to restore nerve signals after myelin is lost suggests it may also reduce other symptoms of the disease, regardless of what other medicines patients are taking, said John Richert, executive vice president of research and clinical programs for the New York-based National Multiple Sclerosis Society.

“Potentially, it could be tried in the large majority of people with MS,” Richert said in an Oct. 7 phone interview. “It has at least the theoretic potential for being able to help with virtually any MS symptom.”

Elan will manufacture fampridine if it is approved and receive royalties on sales. The drug is the first that Acorda has submitted to the FDA. The company also sells Zanaflex capsules, a treatment for spastic muscles that it acquired from Elan in 2004.

Biogen Partnership

Cambridge, Massachusetts-based Biogen agreed in July to pay as much as $510 million for rights to market fampridine outside the U.S. after Acorda said it wouldn’t be able to operate beyond next year without a partner. Naomi Aoki, a spokeswoman for Biogen, didn’t immediately return a call seeking comment.

German drugmaker Merck asked the FDA last month to approve cladribine tablets to reduce relapses of MS. Novartis, of Basel, Switzerland, plans to submit its experimental pill, FTY720, to U.S. regulators by the end of the year to reduce relapse and progression of disability. Paris-based Sanofi-Aventis SA is also in late stages of testing its teriflunomide pill for MS.

“Patients tell us they’re desperate for an oral drug,” Richert, of the MS Society, said. “We know that some people don’t go on medication in the first place because they can’t stand the thought of injection.”

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MS Patients May Soon Benefit from a New Generation of Oral Drugs

Multiple sclerosis (MS) is the most common chronic disabling disease of the nervous system. According to the U.S. National Institute of Allergy and Infectious Diseases, MS afflicts one in 700 people in the United States. MS is a relapsing, frequently progressive disorder that affects the myelin sheath or fatty cover of the central nervous system in the brain and spinal cord and results in motor and movement impairment. Because MS primarily affects young adults in their 20s and 30s, the economic and social impact is significant.

The last ten years have seen improvements in the therapeutic options available to MS patients. Injectable interferons have demonstrated the ability to control MS symptoms, but not without side effects. The reformulation of Copaxone has provided an alternative efficacious drug option. The performance of these drugs in effectively treating MS has led to a measure of relief for patients and financial success for drug suppliers. Now a number of oral drugs for treating various forms of multiple sclerosis have reached late-stage clinical development, and their eventual commercialization could have a significant impact on the market for MS therapeutics.

“Suppliers of the top five FDA approved drugs for treating MS recognized a total of $8.5 billion in 2008,” explains George Perros, Greystone Associates Managing Director. “The top four recorded average ex-manufacturer revenues of $ 2 billion, and we expect the fifth, Tysabri, to reach the billion mark in 2010. All five are delivered by either injection or IV. Oral drug candidates in late-stage development are now preparing to spoil the party.”

A new research study, Autoimmune Disease Therapeutics: Targets, Technologies, Therapies, Markets and Opportunities, examines the current therapeutic landscape for MS and five other key autoimmune diseases. The study analyzes key late-stage candidates and their probable impact on treatment strategies and prescribing trends. It also identifies the key players in each therapeutic segment, describes the regulatory and commercial environment, and assesses the dynamics of patient care that will affect market development.

Source : www.huliq.com

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Two New Drugs May Fight Multiple Sclerosis

Two new oral drugs cut by about half the relapse rate in people with multiple sclerosis (MS).

If approved by the FDA, the drugs -- cladribine and fingolimod -- would become the first treatments for MS that don't involve regular injections or infusions.

In one study, about 80% of MS patients who took the chemotherapy drug cladribine were relapse-free for two years vs. 61% given placebo.

In a second study, 80% to 84% of MS patients taking the immune-suppressing drug fingolimod were relapse-free after one year of daily treatment, compared with 67% of those taking the standard injectable MS drug Avonex.

Either drug will meet a huge unmet need as "a lot of patients refuse to go on treatment right now because it involves injections," says Lily Jung, MD, medical director of the neurology clinic at the Swedish Neurology Institute in Seattle. Jung was not involved in either study.

Both studies were presented at the annual meeting of the American Academy of Neurology.

Cladribine Fights Multiple Sclerosis

Cladribine, already licensed for treating leukemia under the brand name Leustatin, suppresses the autoimmune responses thought to cause MS. In MS, T cells -- the "generals" of the immune system -- go haywire and order attacks on the myelin sheaths that surround and protect the brain cells.

"Cladribine damages the ability of the T cells to reproduce and proliferate," Jung says.
The new phase III study involved about 1,200 patients with the relapsing form of multiple sclerosis, characterized by repeated relapses with periods of recovery in between. They suffered from the disease for an average of six to seven years, and all had at least one relapse in the year before entering the study.

Patients were given either four courses of low-dose cladribine tablets or six courses of higher-dose cladribine tablets, or a placebo.

Each course consisted of one to two tablets per day for four or five days, "meaning that individuals with MS only have to take tablets for eight to 20 days a year," says Gavin Giovannoni, MD, of the Barts and London School of Medicine and Dentistry, which led the study.
That should improve compliance, he says.

The patients were followed up for nearly two years and monitored using MRI scans.

Cladribine Cuts Relapse Rate

Compared with patients who were taking a placebo, those taking cladribine were 55% to 58% less likely to suffer a relapse in a year and 33% less likely to suffer worsening in their disability, such as having more trouble walking.

MRI scans showed that patients taking cladribine also had significantly fewer lesions in the deep parts of the brain or spinal cord that are characteristic of MS.

The drug was relatively safe. The most commonly reported side effects were headaches, colds and the flu, and nausea.

Still, the long-term concern is that "we need T cells to fight infections, particularly viral infections. So we'll have to keep an eye on this," Yung says.

"These results are really exciting," Giovannoni tells WebMD. "They have the potential to make a big difference in the lives of patients with MS."

Manufacturer Merck Serono, which funded the study, says it plans to seek FDA approval in the coming months.

Fingolimod Fights MS

Fingolimod also suppresses the autoimmune responses thought to cause MS, but in a different way. It's a molecule that locks T cells inside the lymph nodes, so they can't float around in the bloodstream and make their way to the brain and spinal cord. It was originally designed to help prevent organ rejection in kidney transplant patients, but that didn't work out very well, Jung says.

In that phase III study, more than 1,200 patients with the relapsing form of MS received one of two doses of fingolimod or Avonex daily for one year.

They suffered from the disease for an average of seven years, and all had an average of two relapses in the two years before entering the study.

Compared with patients who were taking Avonex, those taking fingolimod were 38% to 52% less likely to suffer a relapse in a year. They also had fewer new lesions and fewer lesions overall than those on the injectable drug.

The study wasn't long enough to show an effect on disability, says study head Jeffrey Cohen, MD, of the Cleveland Clinic.

The most common side effects were head colds, headache, and fatigue. But there were also eight cases of skin cancer and four cases of breast cancer. It is unclear whether the drug was responsible for the events.

Jung again cautions that longer-term data are needed. Fingolimod is a potent inhibitor of immune responses and patients are being watched carefully, she notes.

Two other large studies of fingolimod are still ongoing, with results expected later this year. Drugmaker Novartis, which funded the current trial, hopes to apply for FDA approval by the end of 2009.

Source : www.webmd.com

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Novartis Drug Heralds Multiple Sclerosis Advances

The first in a new wave of multiple sclerosis medicines, from drugmakers led by Novartis AG and Merck KGaA, may reach the market next year, making therapy more convenient for patients and boosting profits.

In Seattle this week, the drugmakers will present results from human trials of two oral drugs. If the products win U.S. approval, patients for the first time will be able to take pills, rather than shots or transfusions, to slow the nerve- damaging condition. Five more pills and two infusion therapies may join the $7.5 billion a year MS market by 2014, according to the National Multiple Sclerosis Society in New York.

Progress against MS is coming on three fronts, said John Richert, a doctor who leads research at the society. The new drugs may reduce the frequent relapses most patients face. Improved detection may allow earlier treatment before symptoms emerge. Stem-cell therapies now being tested may go even further, reversing disability in patients with advanced disease.
“In terms of stopping disease activity, there are more therapies coming onstream than ever before and many of these also appear to be more potent,” Richert said in a telephone interview. “While the whole idea of repairing the nervous system really seemed like science fiction five to six years ago, advances in the last year suggest this may well be within our grasp.”
Novartis was unchanged at 42.46 Swiss francs in Zurich trading. Merck KHaA, which today reported a decline in first- quarter profit and said “the bottom” had been reached, advanced 1.2 euros, or 1.8 percent, to $67.70 euros in Frankfurt trading.

Rogue Cells

First described 140 years ago, multiple sclerosis causes the body to attack itself through the immune system. Rogue immune cells travel to the brain and spinal cord and enter the nervous system. There the cells assault and destroy myelin, the fatty substance that surrounds nerve-cell fibers. That interferes with the nerve cells’ ability to transmit electrical impulses and move muscles.

MS generally starts in early adulthood, disrupting people’s coordination and balance and sometimes leading to damaged vision and paralysis. For Rhonda McHenry, a fall in 1994 while chasing her then 9-month-old son, and the resulting nerve pain, led to an MS diagnosis.
McHenry, now 44, was diagnosed with the “relapsing- remitting” form of MS that makes symptoms flare and recede and that 85 percent of patients have initially, according to the MS Society.

Drugs Against Relapse

In one way, she was fortunate. Around the time of her diagnosis, three new drugs were approved to prevent MS relapses. They included two made from proteins called beta interferons -- Avonex, made by Biogen Idec Inc. of Cambridge, Massachusetts, and Betaferon, made by Bayer AG of Levrkusen, Germany. The third treatment is Copaxone, made by Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel, from a synthetic protein.

The treatments included Avonex, made by Biogen Idec Inc. of Cambridge, Massachusetts; Betaferon, made by Bayer AG of Levrkusen, Germany; and Copaxone, a product from Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel.

These products, along with Rebif, made by Merck KGaA, of Darmstadt, Germany, inhibit the overactive immune response found in MS, reducing damage to nerves and slowing disability, Richert said. Rebif was approved by the U.S. Food and Drug Administration in 2002.
The four, known by their initials as the ABCR drugs, now dominate the MS marketplace, with more than $1 billion each in sales annually. Biogen’s Avonex led the pack with $2.2 billion last year. Geoffrey Porges, an analyst with Sanford C. Bernstein & Co. in New York, projected in a report last year that the MS market will grow to $10.8 billion in 2013.

Blocking Cell Movement

As researchers have learned more about how the immune system attacks nerves, they have been able to design drugs that interfere with that process, Richert said.

The newest MS treatment on the market, Biogen’s Tysabri, blocks the movement of immune cells from the bloodstream into the nervous system.

The experimental Novartis drug FTY720 disrupts the movement of immune cells at an earlier stage than Tysabri, keeping them from leaving lymph nodes and entering the bloodstream, according to Richert.

German Merck is attempting to turn a cancer drug, cladribine, into an MS medicine because it suppresses the immune system, blunting its attack on nerve cells. The product was approved to treat leukemia more than a decade ago.

Results Next Week

Novartis, based in Basel, Switzerland, and Merck will release results this week at a Seattle meeting of the American Academy of Neurology, a professional association based in St. Paul, Minnesota. Preliminary findings already released by both companies suggest that the drugs limit relapses.

The data on side effects may determine if and when the products will take revenue from the Bayer, Biogen and Teva products, said Jack Scannell, a London-based analyst with Bernstein.
Merck plans to submit its FDA application in June or July, said Bruno Musch, the company’s head of global clinical development for neurodegenerative diseases. Novartis intends to make its submission by the end of the year, said Joseph Jimenez, head of the pharmaceutical division, in a conference call last week.

MS Pills Advance

Other companies are also racing to bring MS pills to market. Acorda Therapeutics Inc., based in Hawthorne, New York, said on April 23 it had reformatted and resubmitted an application for a pill called Fampridine-SR. The drug improved the walking speed of MS patients in a study, according to the company.

Biogen, the leading maker of MS therapies; Teva; and Sanofi-Aventis SA, of Paris are conducting late-stage trials of their own MS pills. An injectable drug called Campath, being developed by Cambridge, Massachusetts-based Genzyme Inc. and Bayer, may be the most effective therapy for people with severe MS, according to Porges. He projects Campath revenue will top $1 billion by 2013.

Data on side effects of all the new therapies will be closely watched because drugs that disrupt immune system activity can increase the risk of infections, Richert said.

Tysabri was pulled from the market in 2005 after three patients developed a life-threatening brain illness and two of them died. The FDA allowed Tysabri sales to resume in July 2006 after deciding its effectiveness outweighed the risk. The company has since reported six new cases, with one death.

Side Effects

If the new pills cause side effects, that may negate their advantages, said Al Sandrock, senior vice president of neurology for Biogen, whose drug BG-12, also taken by mouth, is in late- stage testing.

“The safety profile is never fully appreciated until a drug has been in thousands of patients for many years -- we certainly learned that,” Sandrock said.

Elizabeth Morrison, a neurologist at the Cascadia Multiple Sclerosis Center, a medical practice in Bellingham, Washington, has MS herself. She said she will probably keep taking Copaxone, as it controls her symptoms without causing side effects such as chest pain or anxiety, which patients can experience.

She also said she won’t rush to prescribe the new drugs for other patients.
“I think people with MS may think, ‘Oh, an oral medication -- that will be safer or easier for me,’” she said in a telephone interview. “But that’s not necessarily the case.”

Doctors will be cautious in prescribing the new pills until their safety is clear, said Bernstein’s Scannell.

Convenience vs. Risk

“The fact that they’re convenient and oral doesn’t trump the fact that they might give you a horrible brain infection or cancer,” he said in a telephone interview.

In addition to having more and better drugs, clinicians can now find MS lesions using MRI scans earlier than ever before, said Peter Wade, medical director for neurology at the Mandell Center for Multiple Sclerosis, at Mount Sinai Rehabilitation Hospital in Hartford, Connecticut.
“Now there is an urgency to diagnose the disease as quickly as possible because the medications we have currently available work much more effectively early on,” Wade said in a telephone interview.

For patients with advanced disease, early detection is no longer relevant.

For most of the past 15 years, daily injections of Copaxone have controlled Rhonda McHenry’s relapses and when they didn’t, five days of intravenous steroids usually cut them short.
Today, the relapses come more often, last longer and cause more weakness, making walking more difficult for McHenry, who is today the chief operating officer for a Kansas City bank. Now she hopes she will be lucky again and benefit from new therapies.

Clinical Trial

She qualified for a clinical trial that will use patients’ own stem cells to reset their immune systems. Patients will have their blood-forming stem cells extracted before chemotherapy drugs kill the immune cells in their bone marrow. The stem cells will then be returned to rebuild their marrow, creating a fresh batch of immune cells.

The immunologist leading the study, Richard Burt of Northwestern University’s Feinberg School of Medicine in Chicago, reported in January that the procedure reduced disability in 21 patients in a pilot trial. He and his colleagues aim to show by the end of 2012 that the therapy can roll back symptoms in a 110-patient trial.

McHenry, who is scheduled to start the stem-cell treatment in July, said she hopes it will halt the worsening of her disease before it causes more-severe disability.

“If it were to stop the progression, even for five years, that gives me five more years to live life and enjoy it,” she said. “If not, I hope they learn from me what it’s going to take to make it work for someone else.”

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New Drug Therapy May Improve Mobility For Multiple Sclerosis Patients

Multiple Sclerosis (MS) affects about 400,000 Americans and approximately 2.5 million people worldwide, according to the National Multiple Sclerosis Society. It is a chronic and often disabling disease that attacks the brain, spinal cord, and optic nerves that make up the central nervous system. Symptoms can range from numbness in the limbs to debilitating paralysis and loss of vision. The symptoms, as well as the progression and severity of MS, are unpredictable and may vary greatly from one person to another.

MS is an autoimmune disease in which the body’s own defense system attacks a fatty substance called myelin that surrounds and protects the nerve fibers in the central nervous system. The damaged myelin forms scar tissue, or sclerosis. Nerve fibers can be damaged as well. MS patients suffer from a progressive decline in mobility and few treatment options are available beyond physical therapy. However, a new drug developed by Acorda Therapeutics Incorporated, known as fampridine, has now been shown to improve walking ability in some multiple sclerosis patients. The report on the analysis was published in The Lancet.

Andrew Goodman of the University of Rochester Medical Center in New York, and colleagues, conducted the phase III study of 301 patients ranging in age from18 to 70. Participants were randomly selected to receive either 10 milligrams of fampridine or a placebo twice daily for a period of 14 weeks. Assessments were made of the participants’ walking speeds for a distance of 25 feet after periods of two weeks, six weeks, 10 weeks and 14 weeks.

The results of the study revealed that 35 percent of the participants who received fampridine achieved a faster walking speed in a minimum of three of the four assessments compared to only 8 percent of those taking placebo. In addition, those participants taking the fampridine showed greater improvement in leg strength, improving their ability to participate in daily activities such as standing, walking outside, and using stairs.

A total of 5 percent of the participants withdrew from the study due to adverse events including two participants suffering from the severe adverse events of focal seizure and severe anxiety in connection with use of the drug. The researchers noted that in previous studies, the risk of seizure appeared to increase in accordance with dosage of fampridine.

In conclusion, the researchers wrote, “Treatment with fampridine produces clinically meaningful improvement in walking ability in some people with multiple sclerosis, irrespective of disease course type or concomitant treatment with immunomodulators.” The team also noted that more research would be necessary to confirm the study findings.

There is no known cure for MS. According to Goodman, existing drugs target slowing the progression of the disease and helping to prevent relapses, although patients may not be able to tell whether or not they are working. He explained that with fampridine pills, the patients know if it is working.

In a statement, Dr. Ron Cohen, president and CEO of Acorda Therapeutics, said, “This trial included both physician and patient assessment scales that demonstrated both improvement in walking speed and clinical meaningfulness of that improvement.” He went on to say, “The results of this study indicate that fampridine-SR could potentially represent an important new treatment option in managing MS.”

Although fampridine has shown success in the improvement of visual function, strength, walking ability, fatigue and endurance in MS patients, concerns remain as to the safety and effectiveness of the drug. Acorda submitted a new drug application for fampridine to the U.S. Food and Drug Administration on January 30th. If approved, it would be the first MS drug to reverse a symptom of the disease.

Source : www.healthnews.com

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