Salix Pharmaceuticals, Inc. recieved disappointing news when the U.S. Food and Drug Administration (FDA) postponed the previously scheduled meeting on Mar 10–11 to consider the Supplemental New Drug Application (sNDA) for Relistor.
Relistor is a subcutaneous injection that is currently approved for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
Salix is looking to get Relistor approved for use in chronic non-cancer pain in patients with OIC. We note that Salix acquired the worldwide rights to Relistor (excluding Japan) from Progenics Pharmaceuticals, Inc. in Feb 2011.
We remind investors that Salix had received a complete response letter (CRL) from the FDA in Jul 2012 for its sNDA on Relistor. In the CRL, the FDA had asked for additional data. Subsequently, in Jun 2013, Progenics and Salix announced that the FDA’s advisory panel will review Salix’s sNDA for Relistor for OIC in patients with chronic pain.
The Anesthetic and Analgesic Drug Products Advisory Committee of the FDA was supposed to meet on Mar 10-11 to address the questions surrounding the class of mu opioid antagonists being developed for OIC. The meeting was scheduled on the request of Salix. However, the FDA cited substantial scheduling conflicts and postponed the meeting.
We were disappointed by the delay in meeting with the FDA which clearly causes uncertainty in the mind of investors.
Currently, Sucampo Pharmaceuticals, Inc.’s Amitiza is the approved treatment for OIC in patients with chronic pain. In Jul 2013, Amitiza was launched in the U.S. for the treatment of OIC in adults with chronic, non-cancer pain.
Salix currently carries a Zacks Rank #1 (Strong Buy). Currently, Forest Laboratories Inc. also looks attractive with a comparable Zacks Rank #1.