FDA Advisory Committees Reject Oxycodegol (NKTR-181) Application

In January, the U.S. Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) voted against recommending approval for the new drug application for oxycodegol (NKTR-181), an experimental opioid analgesic.¹ The treatment is designed to manage chronic low back pain in adults with pain severe enough to require daily, long-term opioid treatment and for whom alternative treatments are inadequate.

At the advisory committee meeting, concerns were raised about the drug’s potential for misuse or abuse. Specifically, committee members cited a lack of data regarding oxycodegol’s potential effects when snorted or injected, as well as its potential for liver toxicity. Members felt too much data were missing and, therefore, they couldn’t determine if the benefits of using oxycodegol outweighed its risks.²

The drug’s manufacturer, Nektar Therapeutics, says oxycodegol is the first full mu-opioid agonist designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction. The company has also stated that if oxycodegol were to be snorted or injected, the drug’s rate of crossing into the brain would be similar to that of orally administered opioids. However, these data were absent from the new drug application.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Nektar Therapeutics. News release: Nektar issues statement regarding FDA advisory committee vote for oxycodegol. 2020 Jan 14.
2. Nektar Therapeutics. News release: FDA panel rejects Nektar’s opioid analgesic NKTR-181 citing safety concerns, lack of data. FirstWord Pharma. 2020 Jan 14.