FDA Approves New Drug for Chronic Anal Fissure Pain

Mark Crane

June 22, 2011

June 22, 2011 — 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.

"Nitroglycerine is a nitric oxide donor that promotes relaxation of smooth muscle fibers such as those found in the internal anal sphincter and arterial walls," Scott Strong, MD, a colorectal surgeon from the Digestive Disease Institute at the Cleveland Clinic, Ohio, told Medscape Medical News. "Nitroglycerine in concentrations of 0.2% to 0.4%...has been used in other countries for 2 decades as topical treatment for chronic anal fissures, and is now considered by many experts to be a well-established first-line therapy," he noted.

"A Cochrane review of 15 trials studying topical nitroglycerine's use for chronic anal fissures was published in 2009, and it reported a significantly better healing rate associated with nitroglycerine (49%) compared to placebo therapy (37%)," Dr. Strong said.

"The most common side effect of topical nitroglycerine therapy is headache, which affects one quarter of patients," he said. "Although the headache is often minor and temporary, it may lead to discontinuation of therapy in 10% to 20% of patients. Although increasing concentrations of nitroglycerine provide improved likelihood of chronic fissure healing, those higher concentrations are also associated with a greater frequency of headache."

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.

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