The Food and Drug Administration has delayed an expert panel meeting for an investigational opioid painkiller, causing shares of the company developing it to drop.
In a filing with the Securities and Exchange Commission Thursday, San Francisco-based Nektar Therapeutics said it had received notice that the FDA would postpone product-specific advisory committee meetings regarding opioid analgesics “while the agency continues to consider a number of scientific and policy issues relating to this class of drugs.”
That postponement also delays the scheduled Aug. 21 meeting that would have included a discussion of Nektar’s regulatory approval application for the drug NKTR-181, an opioid that the company has been developing for pain. Consequently, the agency may not be able to reach a decision of whether or not to approve the drug by the original Prescription Drug User Fee Act (PDUFA) deadline of Aug. 29, according to the filing.
Nektar describes NKTR-181 as the first full mu-opioid agonist that is designed to provide pain relief without the euphoria that leads to opioid abuse and addiction.
Shares of Nektar fell about 10 percent on the Nasdaq following the news, but since then had begun rising again Friday.
In the SEC filing, the company noted that the postponement was not unique to NKTR-181, and that the FDA would continue to review the application for the drug according to the original timeline. Though not named in the filing, painkillers usually fall under the authority of the Anesthetic and Analgesic Drug Products Advisory Committee.
“We are encouraged by the fact that the FDA stated in their general advice letter to us that they intend to continue the review of NKTR-181’s [New Drug Application] according to the existing PDUFA deadline,” wrote Jennifer Ruddock, Nektar’s senior vice president for strategy and corporate affairs, in an emailed statement. “They’ve also communicated that they hope to reschedule the postponed advisory committee meeting and take action before the end of this year.”
The FDA did not respond to a request for comment.
If the agency fails to reach a decision by the Aug. 29 PDUFA date, it will have to pay back some or all of Nektar’s application fees, noted David Gortler, a former FDA official who now does regulatory consulting and teaches pharmacology at Georgetown University.
“I understand that they’re reviewing some policy issues, but if the FDA acts on this responsibly, they should go back to reviewing this drug right away,” Gortler said in a phone interview. A drug that is able to treat pain without the effect of addiction would be something that holds promise for people who are sick, he explained.
Also last week, shares of New York-based Intra-Cellular Therapies fell sharply after the FDA canceled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for Wednesday for the drug lumateperone in schizophrenia. The stated reason was that the meeting had been canceled so that the agency could review new and any forthcoming information regarding the company’s regulatory approval application for the drug. The PDUFA date for lumateperone is Sept. 27, but new information could end up extending the date, the company said.
Photo: FDA, Flickr (free of all copyright for use and redistribution without restriction)