After FDA committees vote 27-0 against recommending the NDA for NKTR-181, Nektar Therapeutics announced they were withdrawing the application and canceling the program.
After a US Food and Drug Administration (FDA) committee voted unanimously to not recommend the NDA for oxycodegol (formerly NKTR-181) for the treatment of chronic lower back pain, Nektar Therapeutics announced it has decided to withdrawal the NDA and to abandon the program.
Nektar announced the move in a press release following the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) voted 27-0 on Tuesday—stating company was disappointed in the vote and believes it is disappointing move for patients and physicians, alike.
According to a report from Reuters, members of the AADPAC and DSaRM expressed concerns over potential misuse or abuse of the therapy. The report also noted concern over an insufficient amount of data to evaluate the possible abuse when snorted or injected as well as its potential for liver toxicity.
Oxycodogel is a novel, first-in-class opioid molecule developed by Nektar for the treatment of chronic lower back pain in adults with no history of opioid therapy. In the initial NDA, Nektar claimed the treatment’s more gradual effect could lower concerns of dopamine release and associated euphoria seen with other opioids.
The release from Nektar noted the company’s NDA for oxycodogel was backed by the results of multiple studies and the program assessing the therapy included more than 2000 patients and volunteers. Based on the company’s projections of estimated costs related to planned commercialization and post-approval, Nektar expects withdrawing the NDA will result in cost savings of between $75 million and $125 million in 2020.