‘Opioid of the Future’ Abandoned
/By Pat Anson, PNN Editor
A promising new pain medication once touted as the “opioid of the future” because of its low risk of abuse is being abandoned.
Nektar Therapeutics withdrew its new drug application for NKTR-181 (oxycodegol) after two FDA advisory committees voted 27 to 0 against approval of the drug because of lingering concerns about the potential for addiction.
“The Company is disappointed in the Committees' vote regarding oxycodegol and believes it is also disappointing for patients suffering from chronic pain and the physicians that treat those patients who are currently relying on existing opioid therapies,” Nektar said in a statement. “The Company has decided to withdraw the NDA for oxycodegol and to make no further investment into the program.”
The molecular structure of oxycodegol is designed so the drug enters the brain slowly, providing pain relief without the euphoria or “high” that can lead to abuse.
In clinical studies, recreational drug users reported less “drug liking” of oxycodegol compared to oxycodone. Patients with chronic back pain also reported significant pain relief taking the drug twice daily.
The research was so promising the FDA gave oxycodegol “fast track” designation in 2017 to speed its development.
All that changed, however, when the FDA came under a wave of public and political pressure to tighten its regulation of opioids. A 60 Minutes report last year claimed the FDA “opened the floodgates” to the opioid crisis by approving the use of OxyContin. The agency also received a petition from Public Citizen calling for a moratorium on new opioid approvals because the agency “can no longer be trusted” due to its “poor record” of regulating opioids.
The FDA advisory committees had concerns about oxycodegol being snorted or injected by drug abusers and its potential for liver toxicity. A staff briefing document also questioned whether Nektar’s clinical studies were adequate.
While the panels’ unanimous recommendation isn’t binding on the FDA, Nektar decided to withdraw its new drug application rather than invest further resources in oxycodegol. That will save the company $75 to $125 million in 2020, according to a news release.
Drug Distributor Stops Opioid Sales
Nektar’s decision came the same day a New York based drug distributor announced it will no longer sell opioid medications. The Rochester Drug Co-Operative (RDC) is the nation’s sixth-largest pharmaceutical wholesaler. It buys medicines directly from drug manufacturers and sells them to 1,300 pharmacies in the Northeast.
"The ever-increasing expenses associated with the legal and regulatory compliance for this segment of drugs are simply not sustainable," RDC said in a statement. "While these specific drugs represent a relatively small percent of total sales, they account for significant legal and compliance expenses."
Two former RDC executives were charged last year with illegally distributing opioids and conspiring to defraud the government. The company paid a $20 million fine and accepted independent monitoring under a five-year deferred prosecution agreement with the government.
An RDC spokesman said the decision to stop selling opioids was a business decision and not related to the legal case.
