The US Food and Drug Administration (FDA) has approved nitroglycerin ointment 0.4% (Rectiv, ProStrakan Group) for the treatment of moderate to severe pain associated with chronic anal fissures, the company announced today.
The ointment will be the only FDA-approved prescription product for patients with this condition, according to the company. Marketed under the name Rectogesic, the ointment is already approved in the European Union and has been outlicensed outside Europe by ProStrakan to commercial partners in 34 countries worldwide.
"The pain associated with anal fissures can be unrelenting and debilitating. Prompt initiation of treatment by primary care practitioners, gynecologists, gastroenterologists and surgeons alike is critical to a patient's wellbeing," Scott Berry, MD, colorectal surgeon and the principal investigator on one of Rectiv's clinical trials, said in a news release. "Now we have an effective and easy-to-use topical ointment which allows grateful patients to resume their daily lives."
Approximately 700,000 people in the United States receive a diagnosis of or treatment for an episode of anal fissures each year. An anal fissure is a small tear in the skin that lines the anus, and it can occur in many 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. Chronic anal fissure has been shown to significantly affect patients' quality of life, the company said. An episode can take 6 to 8 weeks to heal, and if healing does not occur surgery may be required.
ProStrakan expects Rectiv to be available in the United States in the first quarter of 2012.
ProStrakan, based in Galashiels, Scotland, and Bedminster, New Jersey, is a subsidiary of Kyowa Hakko Kirin Co. Ltd., a Japan-based global specialty pharmaceutical company.