Nektar Withdraws NDA for Opioid Therapy After FDA Committee Vote

January 16, 2020

The FDA Committees voted against recommending approval of Nektar Therapeutics' oxycodegol.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee unanimously voted against the approval of Nektar Therapeutics oxycodegol, according to meeting documents.1

Following the Committees’ decision, Nektar Therapeutics has decided to withdraw its New Drug Application (NDA) for oxycodegol and will make no further investment in the program, the company announced in a statement.2

Oxycodegol, formerly NKTR-181, is a novel, oral, long-acting selective mu opioid receptor agonist that was being evaluated for the treatment of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.1

The committee members pointed out areas of the application that required further investigation, including the proposed indication limiting the product’s use for chronic low back pain and lack of a second well-controlled efficacy study. In the submitted NDA, Nektar indicated that oxycodegol reduced incidence of specific central nervous system-mediated adverse effects, such as euphoria, that is often seen with other opioids.1

In the FDA meeting, members of the panel raised concerns that Nektar did not provide enough data to support its claims.1

Additionally, human abuse potential studies showed that oxycodegal’s oral abuse potential was similar to that of oxycodone, and data to assess the abuse potential of oxycodegol via intravenous or intranasal administration were inadequate.1

“The company is disappointed in the Committee’s vote regarding oxycodegol and believes it is also disappointing for patients suffering from chronic pain and the physicians who are currently relying on existing opioit therapies,” Nektar Therapeutics said in a statement.2 The company indicated that it used “well-established efficacy, safety, and human abuse potential study designs that have led to many prior FDA approvals of opioids medications.”

The development program for oxycodegol included over 2000 patients and volunteers.2

References:

  • FDA. Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee [FDA Briefing Document]. January 14, 2020. https://www.fda.gov/media/134082/download