Tarrytown-based Progenics Pharmaceuticals Inc. announced Nasdaq has halted trading of the drug manufacturer”™s common stock.
The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee is meeting Wednesday and Thursday to discuss the potential cardiovascular risk associated with products in the class of peripherally-acting opioid receptor antagonists.
Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor, to Salix Pharmaceuticals Ltd. Relistor is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness.
The advisory committee was originally announced in June 2013 in response to an appeal by Salix of the FDA’s July 2012 complete response letter in respect to Salix’s supplemental new drug application for Relistor. A complete response letter tells an applicant what changes have to be made before an application can be approved. The FDA has said it will take action under the appeal within 30 days after receiving input from the committee.
