US FDA approves ProStrakan's Rectiv for anal fissures pain

Scotland-based ProStrakan, now a subsidiary of Japan’s Kyowa Hakko Kirin (TYO: 4151) as the result of a recently-completed $474 million takeover (The Pharma Letter February 21), says that it has received US Food and Drug Administration approval for Rectiv (nitroglycerin) ointment 0.4 % for the treatment of moderate-to-severe pain associated with chronic anal fissures. Rectiv will be the only FDA approved prescription product for patients with this condition.

"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," said Scott Berry, colorectal surgeon and the principal investigator on one of Rectiv's clinical trials. "Now we have an effective and easy-to-use topical ointment which allows grateful patients to resume their daily lives," he added.

Peter Allen, chairman of ProStrakan, said: "The market in the US for a prescription medicine to treat chronic anal fissure pain is significant and, having successfully marketed this product in Europe for some years, we are pleased that it will now be made available to patients in the USA. We will now evaluate the most efficient way of bringing this product to market and making it available as widely as is necessary."