New drug may help fibrosis patients
U.S. medical researchers say they have demonstrated the effectiveness and safety of a new drug to treat idiopathic pulmonary fibrosis.
Researchers said the drug, pirfenidone, might become the first FDA-approved medicine to treat the condition.
In a Phase III clinical study, investigators said they discovered the oral anti-fibrotic and anti-inflammatory agent slows the deterioration of lung capacity in idiopathic pulmonary fibrosis patients.
Two multinational, randomized, double-blind, placebo-controlled Phase III trials were designed to evaluate the safety and efficacy of pirfenidone for mild to moderate lung function impairment.
Dr. Roland du Bois, a professor at National Jewish Health in Denver, said the results of the trials are very encouraging for idiopathic pulmonary fibrosis sufferers.
"The safety and tolerability of pirfenidone was reassuring," du Bois said. "The principal side effects experienced by patients in the studies were gastrointestinal discomfort and photo-sensitivity, both of which were manageable in the majority of patients.
"When taken in the context of the urgent unmet medical need for new medicines to treat IPF patients, the collective efficacy and safety data from the … studies, corroborated by a similar study in Japan, make a case for the use of pirfenidone in this disease setting."
The researchers presented their findings Sunday in San Diego during the American Thoracic Society's 105th International Conference.
Source : www.timesoftheinternet.com
Researchers said the drug, pirfenidone, might become the first FDA-approved medicine to treat the condition.
In a Phase III clinical study, investigators said they discovered the oral anti-fibrotic and anti-inflammatory agent slows the deterioration of lung capacity in idiopathic pulmonary fibrosis patients.
Two multinational, randomized, double-blind, placebo-controlled Phase III trials were designed to evaluate the safety and efficacy of pirfenidone for mild to moderate lung function impairment.
Dr. Roland du Bois, a professor at National Jewish Health in Denver, said the results of the trials are very encouraging for idiopathic pulmonary fibrosis sufferers.
"The safety and tolerability of pirfenidone was reassuring," du Bois said. "The principal side effects experienced by patients in the studies were gastrointestinal discomfort and photo-sensitivity, both of which were manageable in the majority of patients.
"When taken in the context of the urgent unmet medical need for new medicines to treat IPF patients, the collective efficacy and safety data from the … studies, corroborated by a similar study in Japan, make a case for the use of pirfenidone in this disease setting."
The researchers presented their findings Sunday in San Diego during the American Thoracic Society's 105th International Conference.
Source : www.timesoftheinternet.com
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