AstraZeneca cheered by FDA's decision to avoid cardiovascular trial

13th Jun 2014 07:06

AstraZeneca has welcomed a vote by a committee of the US Food and Drug Administration (FDA) against the necessity of a trial looking specifically into cardiovascular outcomes of its Movantik drug, which has been developed to treat constipation associated with opioid pain medications. The meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain.Following a clarification of the vote, the majority of the committee suggested continued post-approval data collection for cardiovascular safety. Briggs Morrison, Executive Vice President of Global Medicines Development and Chief Medical Officer, said: "We are pleased that the Committee did not find it necessary to require a cardiovascular outcomes trial for the Pamora class. "We look forward to the outcome of the FDA's review of the New Drug Application for Movantik and the potential to provide patients with chronic non-cancer pain affected by OIC with an additional treatment option."NR