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FDA Panels Show Little Love for New Painkillers

Two drugs get thumbs-down; two get split decisions


by Judy George, Senior Staff Writer, MedPage Today
January 17, 2020

FDA advisory committees had little love for investigational painkillers this week, soundly rejecting two proposed drugs and deadlocking decisions on two others.

Thumbs-down went to Nektar's oxycodegol for chronic low back pain -- which earned a stunning 27-0 rejection -- and Intellipharmaceutics' oxycodone extended-release tablets known as Aximris XR, which was slammed down 24-2.

Split decisions went to Durect's bupivacaine depot (Posimir), a post-surgical non-opioid painkiller that would be injected directly into a surgical incision, in a 6-6 vote, and Esteve Pharmaceuticals' combination of the mild opiate tramadol and the anti-inflammatory drug celecoxib (Celebrex), which earned a 13-13 tie.

Much concern centered on the potential harms of putting new painkillers on the market, especially new opioids, without fully understanding their abuse potential. As advisory committee member Steve Meisel, PharmD, of Fairview Health Services in Minneapolis, said at the oxycodegol review: "We can't approve a drug in the midst of a public health crisis on the basis of speculation."

Oxycodegol's 27-0 rejection caused drug maker Nektar Therapeutics to withdraw its FDA application for FDA approval and make no further investment in the drug, issuing a statement that "this will afford Nektar cost savings of between $75 million to $125 million in 2020 based upon its projections of the estimated costs related to commercialization plans and post-approval studies previously discussed with the FDA."

An equally bleak future may face Aximris XR (formerly known as Rexista), an abuse-deterrent, controlled-release oral formulation of oxycodone hydrochloride developed for long-term, around-the-clock pain relief. "There can be no assurance that the FDA will ultimately approve the [new drug application] for the sale of Aximris XR in the U.S. market, or that it will ever be successfully commercialized," Intellipharmaceutics said in a statement after the meeting.

For the other two drugs, the jury is still out. The advisory panel deadlocked about recommending the tramadol 44 mg/celecoxib 56 mg combination from Esteve, based in part by data shown by the FDA at the meeting. While the relatively weak opiate tramadol was less frequently implicated in prescription drug abuse than hydrocodone and oxycodone, tramadol-involved overdoses increased from 2011 to 2017, the agency pointed out.

And in the case of Durect's post-surgical non-opioid bupivacaine injection Posimir, efficacy and adverse event data outlined by the FDA in its review weighed heavily in panelists' minds. "It is slightly better than placebo, but very slightly better," said panelist Abigail Shoben, PhD, of Ohio State University in Columbus, who voted against recommending the drug.

Despite a split decision from the FDA advisors, Durect remained optimistic about Posimir's future: "We are encouraged by the support from a number of the committee members," Durect's President and CEO, James Brown, said in a statement released after the meeting. "We continue to believe the data meets all of the regulatory requirements and that the weight of the evidence supports approval."

FDA advisory committee recommendations are non-binding, though the agency considers them during the approval process, and often follows their lead. Final decisions about regulatory actions are made by the FDA.