Painful wait for ProStrakan on Abstral's US approval

Following the recent US Food and Drug Administration delay in approving ProStrakan's Abstral (The Pharma Letter June 3), the company now awaits an FDA judgment on its sublingual fentanyl product by September 4, and a positive would be one of the few items of good news the Scottish company has heard from the USA this year, comments UK consultancy EvaluatePharma's EP Vantage.

When the agency extended Abstral's PDUFA date from June 4 to seek more information about its risk evaluation and management strategy, the cancer pain drug joined testosterone gel Fortesta and anal fissure treatment Rectogesic (glyceryl trinitrate) in US regulatory limbo, disrupting a bid to have three new products reach the US market this year. Some observers suggest the success of Abstral and Sancuso, a granisetron anti-emetic patch used to combat the side effects of cancer treatment, could transform ProStrakan and, fortunately for the company, good news from the FDA is widely anticipated, the consultants say.

Coupled with lacklustre US sales of Sancuso and concerns about pricing pressures in Europe, the regulatory questions over Abstral have been a headwind for ProStrakan. While some observers took the extension as good news - in that it was not the dreaded complete response letter - investors drove shares in ProStrakan to a 15-month low of 66.5 pence on July 1 before recovering to 75 pence over the last six weeks, EP Vantage notes.