Posted by Michael Wonder on 16 Jan 2020
Nektar issues statement regarding FDA Advisory Committee vote for oxycodegol
15 January 2020 - Nektar Therapeutics issued a statement today following a meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the new drug application 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.
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.
