Nektar Issues Statement Regarding FDA Advisory Committee Vote for Oxycodegol
- Category: Small Molecules
- Published on Wednesday, 15 January 2020 15:22
- Hits: 647
SAN FRANCISCO, CA, USA I January 14, 2020 I Nektar Therapeutics (NASDAQ: NKTR) issued a statement today following a meeting of the Food and Drug Administration's (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 today's 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.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly-owned R&D pipeline of investigational medicines in oncology and immunology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
SOURCE: Nektar Therapeutics