FDA advisory committee does not recommend oxycodegol ( NKTR 181) as a treatment for chronic pain and the drug is withdrawn.- Nektar Therapeutics
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Published:16th Jan 2020
Nektar Therapeutics issued a statement following a meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) to discuss the New Drug Application (NDA) for oxycodegol (formerly NKTR-181) where the Committees did not recommend approval of oxycodegol. 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. The Company created oxycodegol specifically to both help these patients and physicians and address the opioid abuse epidemic. For the development of oxycodegol, the Company used well-established efficacy, safety and human abuse potential study designs that have led to many prior FDA approvals of opioid medications. The development program for oxycodegol included over 2,000 patients and volunteers. As a result of the vote at the meeting, the Company has decided to withdraw the NDA for oxycodegol and to make no further investment into the program. The Company estimates 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.
Condition: Pain;Chronic/Low Back