Prostrakan's anal fissure pain drug refiled with US FDA
This article was originally published in Scrip
The FDA has accepted Prostrakan's re-submission of Cellegesic (nitroglycerin) 0.4% ointment for moderate to severe pain associated with chronic anal fissures, three years after the agency issued an action letter for the troubled drug.
Cellegesic was first filed in the US in 2001 by Cellegy, but has faced repeated setbacks, including a withdrawal, a non-approvable letter and an action letter requesting a further clinical trial to demonstrate efficacy (scripnews.com, July 14th, 2006).
ProStrakan remains optimistic about this latest filing, however, and notes that nitroglycerin-containing products are already widely used to treat severe pain associated with chronic anal fissures in the US, despite not being approved.
Moreover, the drug has fared better outside the US, and is already approved and marketed in the EU as Rectogesic. Prostrakan bought Cellegesic, as well as Tostran (testosterone, 0.5% gel), from Cellegy in 2006 for $9 million.