Shares of Actavis plc (ACT) were up 0.9% after the company announced that the FDA has granted priority review status to its New Drug Application (:NDA) for its gastrointestinal candidate, eluxadoline. Although the company lost 0.2% in the subsequent trading session, shares are up 0.7% since the announcement.
Actavis is looking to get eluxadoline approved for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant irritable bowel syndrome (IBS-D).
With the FDA granting priority review status to the NDA, a response should be out within six months of receiving the regulatory application. We note that the FDA grants priority review status to candidates which have the potential to bring significant improvements in terms of safety or effectiveness in the treatment, diagnosis or prevention of serious diseases when compared to currently available therapies.
Meanwhile, Actavis intends to submit an amendment to the NDA, which would be based on additional data from a study that was in progress at the time of submission. Actavis expects that this may very well push the FDA action date to the second quarter of 2015.
According to the press release issued by Actavis, chronic abdominal pain and frequent diarrhea affect nearly 15 million people in the U.S. The approval of eluxadoline will provide significant benefit to patients suffering from IBS-D. Currently, companies like Salix Pharmaceuticals (SLXP) have a strong presence in the gastrointestinal market.
We remind investors that eluxadoline became a part of Actavis’ portfolio through its recent acquisition of Forest Laboratories. Eluxadoline, on approval, would enter the very lucrative IBS-d market.