ProStrakan Group plc has launched Cellegesic (nitroglycerin ointment) 0.4% (branded Rectogesic outside the US) in the United Kingdom (UK). Rectogesic is a 0.4% topical nitroglycerin ointment for the treatment of the pain associated with chronic anal fissure. On August 25, 2004, the Medicines and Healthcare Products Regulatory Agency (MHRA) approved the product for sale in the UK, announced by Cellegy Pharmaceuticals, partner of ProStrakan.
"The launch of Cellegesic in a major pharmaceutical market is an important milestone for Cellegy," said Richard Williams, chairman and Interim CEO of Cellegy Pharmaceuticals, Inc. "The commercialization of Cellegesic by our partner ProStrakan Group plc in the United Kingdom furthers our objective outlined earlier this year of maximizing overseas commercial cash flows. We look forward to working with ProStrakan, in supporting their launch in the UK and in filing the regulatory submissions, via the mutual recognition procedure (MRP), for the potential approval of Cellegesic across the balance of the European Union," he added.
An anal fissure is a painful tear in the lining of the anal canal and is associated with increased pressure in the anal canal and decreased blood supply of the canal lining. Cellegesic relieves the pain associated with chronic anal fissure by gently relaxing the sphincter muscle. Cellegy believes that the utility of nitroglycerin in treating anal fissures is well recognized and that the Company's product fills a large unmet medical need, says a company release.