SAN FRANCISCO, June 12, 2014 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) reported today that partner AstraZeneca announced that the majority of US Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs, which includes MOVANTIK TM (naloxegol oxalate), an investigational treatment for opioid-induced constipation (OIC) for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety.
The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on June 11-12, 2014. The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of OIC in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee's recommendation, but takes its advice into consideration when reviewing applications for investigational medicines. The Prescription Drug User Fee Act (PDUFA) date set by the FDA for MOVANTIK is September 16, 2014.
"We are exceptionally pleased that the Committee did not find it necessary to require a cardiovascular outcomes trial," said Howard W. Robin, President and CEO of Nektar Therapeutics. "We look forward to the FDA's continued review of the New Drug Application for MOVANTIK and the potential for MOVANTIK to become the first once-daily, oral PAMORA for the treatment of OIC for patients with chronic non-cancer pain."
MOVANTIK was designed using Nektar's proprietary oral, small molecule polymer conjugate technology. MOVANTIK is part of the exclusive worldwide licence agreement announced in September 2009 between AstraZeneca and Nektar.Opioids play an important role in chronic pain relief by binding mu-receptors in the brain, but they also bind mu-receptors in the bowel. That is why patients taking opioids for chronic pain can develop OIC. In fact, the incidence of OIC can be as high as 81% in patients taking opioids. There is a significant unmet need for safe, effective treatment options for patients with OIC. An estimated 235 million prescriptions for opioids are written in the US each year, of which 20% are for chronic pain. For patients taking prescription opioids for chronic pain, constipation is one of the most common side effects and one not adequately relieved by laxatives.