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ARTICLE | Company News

Nektar up on FDA panel decision for OIC

June 14, 2014 12:40 AM UTC

Nektar Therapeutics (NASDAQ:NKTR) jumped $1.35 (11%) to $13.89 on Friday after the majority of panelists on FDA's Anesthetic and Analgesic Drug Products Advisory Committee said on Thursday that cardiovascular outcomes trials weren't warranted for peripheral mu opioid receptor ( OPRM1; MOR) antagonists to treat opioid-induced constipation (OIC) in patients with chronic non-cancer pain. Nektar's Movantik naloxegol, a pegylated form of the peripheral MOR antagonist naloxol, is under review in the U.S. and Europe to treat OIC in patients with chronic non-cancer pain. The PDUFA date is Sept. 16. AstraZeneca plc (LSE:AZN; NYSE:AZN) has worldwide rights to Movantik.

During the Thursday meeting, panel members argued it might not be feasible for companies to conduct large CV outcomes trials in OIC patients because Phase III trials showed a low incidence of major adverse cardiac events (MACE). FDA estimated that with a 1% event rate, outcomes trials would need more than 25,000 patients to rule out a hazard ratio (HR) of 1.5 or about 9,000 patients to rule out a HR of 2 (see BioCentury Extra, June 12). ...