Salix says 'pleased' with FDA Ad Comm recommendations on PAMORAS

June 12, 2014

Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) reported that the Anesthetic and Analgesic Drug Products Advisory Committee of the FDA has provided an assessment of potential cardiovascular risk associated with products in the class of peripherally-active opioid receptor antagonists, or PAMORAS, and recommendations regarding the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in this class for the proposed indication of opioid-induced constipation in patients taking opioids for chronic pain. In the formal vote, twelve committee members voted to not require cardiovascular outcomes trials for PAMORAS being developed for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain. Seven members voted to require CVOTs for all PAMORAS, and five members voted to require CVOTs, but only for specific PAMORAS. In the post vote discussion, five members stated they misunderstood the question and would have voted to not require CVOTs. Specifically, the Committee recommended that observational studies be conducted on a post-marketing basis. Salix Chief Development Officer Bill Forbes said, "We are pleased with the Advisory Committee’s recommendations regarding the approval pathway for PAMORAS. We are optimistic that, with FDA guidance including input from the Advisory Committee, we can bring RELISTOR to market for patients experiencing constipation as a side effect of taking opioids for their chronic pain."