FDA agrees to approve Relistor for non-cancer OIC

Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) and partner Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) said FDA agreed to approve an sNDA from Salix seeking to expand the label for Relistor methylnaltrexone to include treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. Salix was appealing a 2012 complete response letter in which FDA requested additional controlled CV safety data for the peripheral mu opioid receptor ( OPRM1; MOR) antagonist. At a meeting last month, the majority of FDA's Anesthetic and Analgesic Drug Products Advisory Committee felt CV outcomes trials weren't warranted for MOR antagonists in the indication (see BioCentury Extra, June 12).

According to the partners, FDA requested proposed product labeling and a proposal for at least one postmarketing observational study to assess the incidence of major adverse cardiovascular events for Relistor in the indication. Salix said it intends to submit the information "over the next several weeks." Relistor is already approved in at least 58 countries, including the U.S., to treat OIC in patients receiving palliative care when response to laxative therapy has not been sufficient. ...