GALASHIELS, Scotland, and BEDMINSTER, N.J. — ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.
The drug maker, which is a subsidiary of Kyowa Hakko Kirin, said that it received regulatory approval for Rectiv (nitroglycerin) ointment 0.4%. Rectiv currently is the only FDA-approved prescription product for patients with this condition. ProStrakan expects Rectiv to be available in the United States in first quarter 2012.
Approximately 700,000 people in the United States receive a diagnosis or treatment for anal fissures each year. An anal fissure is a small tear in the skin that lines the anus and can occur in a number of ways, such as passing large or hard stools, straining during a bowel movement or following an episode of diarrhea. When an anal fissure occurs, it typically causes severe pain and bleeding with bowel movements.
The product is marketed under the name Rectogesic in the European Union and already is approved in the EU and marketed by ProStrakan in all major European countries.