Nektar Therapeutics will withdraw its application for Food and Drug Administration approval of an experimental opioid painkiller, announcing Wednesday it won’t invest any more money in the drug after an advisory panel unanimously voted against recommending its approval.The company’s decision to abandon the therapy, called oxycodegol, was unusually rapid and marks a disappointing end to years of research. Regulatory filings show Nektar spent at least $250 million on oxycodegol’s development from 2010 through 2018. In voting 27-0 against approval, advisors on the panel cited concerns about the abuse potential of the drug and said there wasn’t enough data to support approval, Reuters reported. Shares of Nektar fell by more than 15% in early Wednesday trading.
The vote is a significant setback for Nektar, which touted oxycodegol, or NKTR-181, as a way to help address the nation’s ongoing crisis of opioid addiction and overdoses. The company designed the medicine to produce a slower onset of euphoric effects, in theory making it a less attractive choice for people looking to get high.
The FDA panel’s decision is “disappointing for patients suffering from chronic pain and the physicians that treat those patients who are currently relying on existing opioid therapies,” Nektar said in a Jan. 14 statement.
In briefing documents and a series of questions for the panel members, the FDA highlighted that the company had only conducted one pivotal efficacy study to support the drug’s review.
“I voted no, even though I liked the idea of what they are trying to do,” said Dr. Sherif Zaafran, a panel member and vice chairman of the clinical governance board at U.S. Anesthesia Partners, according to the Reuters report. “The data, I don’t think at the end of the day was sufficient from the standpoint of efficacy and safety. ”
Nektar last year set up a separate subsidiary to sell the opioid medicine if it won approval. Company executives at the time said they believed a specialized team was better suited to market the treatment.
Because the company no longer needs to spend money on commercialization and post-approval studies for oxycodegol, Nektar said it expects cost savings of $75 million to $125 million this year.
The company’s main focus has been on its work in cancer, where it’s drawn big partners in Bristol-Myers Squibb and Pfizer.
But even in that area, it’s experienced some setbacks. In August, Nektar said Bristol-Myers cut back its commitment to the experimental treatment bempegaldesleukin to five or six trials, from 18 previously.
