BioCentury
ARTICLE | Company News

FDA issues complete response for Relistor

July 31, 2012 12:50 AM UTC

Shares of Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) and Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) slid on Monday after FDA issued a complete response letter for an sNDA for subcutaneous Relistor methylnaltrexone to treat opioid-induced constipation (OIC) in patients with non-cancer pain. According to the partners, FDA requested additional clinical data. The partners would not comment on whether they would need to conduct additional trials. The partners plan to request a meeting with FDA to discuss the letter. Progenics fell $5.41 (50%) to $5.39 on Monday, while Salix slid $6.94 (13%) to $46.25. ...