Nektar noted that the delay is not due to an issue with its novel opioid formulation, but rather with new policies regarding opioids being implemented at the FDA.
Shares of Nektar Therapeutics plunged more than 11% Thursday after the company quietly announced that the U.S. Food and Drug Administration was delaying a planned advisory committee hearing regarding its novel opioid treatment for pain, NKTR-181.
In an 8-K filing with the U.S. Securities and Exchange Commission, San Francisco-based Nektar noted that the delay was not due to any issues or concerns with NKTR-181. The FDA is delaying all advisory committee meetings involving opioid treatments as it forms new policy guidelines surrounding the approval of opioids as the nation continues to grapple with a crisis of addiction. Nektar said the FDA informed the company that it will continue to review the New Drug Application for NKTR-181 according to the existing Prescription Drug User Fee Act timeline and will request any additional information from the company as needed.
In June, the FDA announced a new guidance to assess the benefit-risk of opioid pain medications. The new guidance puts forward a series of standards the FDA will consider when deciding whether or not to approve a new opioid medication.
The FDA accepted the company’s NDA last year and had set a PDUFA date of Aug. 29. Because of the delay in the advisory committee meeting, Nektar said it was informed that the PDUFA date may be extended.
NKTR-181 is a novel, first-in-class, investigational opioid molecule developed for the treatment of chronic low back pain in adult patients new to opioid therapy. Low back pain is the second most common cause of disability for adults in the U.S. and causes a loss of approximately 149 million work days annually. Nektar said those lost days of work are estimated to have a cost of between $100 to $200 billion a year, of which two-thirds is due to lost wages and lower productivity. Because of its novel formulation, Nektar’s NKTR-181 is seen as a potential game-changer in the treatment of pain. Although still an opioid, NKTR-181 is a new molecular entity and is being touted as the first analgesic opioid molecule to exhibit a low incidence of specific CNS-mediated side effects, such as euphoria. When the company filed its New Drug Application with the FDA last summer, Nektar said NKTR-181 is designed to have low permeability across the blood-brain barrier, which lowers concerns of dopamine release and the associated euphoria.
In May, Nektar launched a new subsidiary called Inheris Biopharma, Inc to support the commercialization of NKTR-181. The new company is helmed by Merck veteran Jay Galeota. “The potential for a novel advance in the treatment of chronic pain is particularly important right now given the opioid abuse crisis in our country,” Galeota said at the time the company was announced.
Despite the drop in stock price on Thursday, investors have come back this morning. Shares are up about 2% to $30.57 before lunch.
