FDA Panels Unanimously Vote Down Approval Of New Chronic Pain Opioid

Members of two FDA advisory committees unanimously voted 27-0 against approving Nektar Therapeutics’ oxycodegol opioid for management of chronic low back pain. During the joint committee meeting on Tuesday (Jan. 14), advisors took issue with the lack of efficacy data for broader patient populations, and they were especially disappointed that the sponsor had only conducted one phase III efficacy study. Advisors also expressed concern that, if approved, the opioid would be perceived as being a “safer” opioid and prescribed and...