Progenix trading halted while Ad Comm meets

|By:, SA News Editor

The NASDAQ halts trading of Progenix Pharmaceuticals (PGNX) while the FDA's Anesthetic and Analgesic Drug Products Ad Comm meets today and tomorrow to discuss the potential cardiovascular risks associated with peripherally-acting opioid receptor agonists and the design and size of cardiovascular outcomes trials needed to support the approval of drugs in the class for the indication of opioid-induced constipation (OIC).

The Ad Comm meeting was originally announced in June 2013 in response to an appeal by Progenics' collaboration partner Salix Pharmaceuticals (SLXP) of a CRL it received in July 2012 regarding its NDA for Relistor (methylnaltrexone bromide) for the treatment of opioid-induced constipation in patients with chronic non-cancer pain.

The FDA stated that it will take action under the appeal within 30 days after receiving input from the Advisory Committee.

Trading in Nektar Therapeutics (NKTR) has been halted as well. Its product candidate for OIC is Movantik (naloxegol oxalate).

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