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FDA Delays AdComm For Nektar’s Pain Drug A Month Ahead Of Decision Deadline

In May, Nektar Therapeutics handed off its lead pain drug to its new subsidiary Inheris so it could focus on its cancer and immunology pipeline. Now, that company is hitting a roadblock as the FDA puts off an advisory panel meeting for the drug, a mu-opioid agonist.

The FDA told Nektar in a General Advice letter Tuesday that it would postpone the advisory committee meeting, originally scheduled for Aug. 21, the company revealed in a Securities and Exchange Commission filing. The FDA will keep reviewing the submission for the drug, NKTR-181, with an eye on the Aug. 29 PDUFA date, but said it could miss that deadline. Nektar’s stock dropped nearly 11% Thursday.

The agency is delaying the meeting as it “continues to consider a number of scientific and policy issues relating to this class of drugs,” Nektar said in the filing. “The Letter stated that the FDA’s reason for postponing the advisory committee meeting for NKTR-181 is not unique to the NKTR-181 product.”

The setback comes amid a reckoning for opioids and the companies that make them. The attorneys general of Massachusetts and New York filed lawsuits earlier this year accusing Purdue Pharma of aggressively pushing to expand the market of OxyContin, even after the company admitted in 2007 that it had “misrepresented the drug’s addictive qualities and potential for abuse.”

NKTR-181 is a long-acting mu-opioid agonist designed to east pain without triggering the euphoria that can lead to abuse and addiction. It does this by crossing the blood-brain barrier more slowly than conventional opioids. It bested placebo in improving pain scores for patients with chronic low back pain, meeting its primary endpoint in a phase 3 study.

“While it’s still certainly possible that the FDA can complete its review of NKTR-181 in time for a potential launch in early 2020, we believe there’s a reasonable chance that the launch will now be delayed while the agency formalizes its position on opioid analgesics in the coming months,” wrote Jefferies analysts David Steinberg and Edward Chung in a note Thursday.

“Given this unusual situation and dearth of historical examples to use as templates, our ‘best guess’ is to now assume a one year delay for NKTR-181 and project product launch in 1H21. Importantly, there is no indication that the FDA will no longer approve opioids for pain management at this point—although that always remains a possibility given the severity of the current crisis.”

The analysts still consider NKTR-181 a “meaningful, safer treatment option” for patients with chronic pain, but dropped their peak sales estimate for the drug from $500 million to $350 million thanks to “ongoing contraction in the opioid market.” – Fierce Biotech

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