Nektar withdraws oxycodegol NDA after negative advisory panel vote

Tuesday’s 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) did not recommend approval of oxycodegol, by a vote of 27 to 0.

The drug’s developer, US biotech firm Nektar Therapeutics (Nasdaq: NKTR), said it 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’s shares plunged 15.2% to $27.96 in after-hours trading on Tuesday, having ramped up 31% since the previous Thursday, in anticipation of a positive vote on the drug.