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Nektar to discontinue opioid medicine after US FDA panel's rejection

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Nektar to discontinue opioid medicine after US FDA panel's rejection

Nektar Therapeutics said it was discontinuing the development of its opioid medication oxycodegol after advisers to the U.S. Food and Drug Administration recommended against the medicine's approval.

The San Francisco-based biopharmaceutical company filed for the drug's approval in May 2018 and formed a new business unit a year after to commercialize the medicine as a back pain treatment. Nektar touted the oral drug, which is also called NKTR-181, as an opioid molecule that has reduced occurrences of central nervous system-related side effects, such as euphoria.

Nektar said in May 2018 that the medicine "separates analgesic efficacy from the high levels of euphoria that too often lead to the abuse and addiction of traditional opioids."

However, a panel of independent advisers on Jan. 14 voted unanimously against approval, citing concerns over the chances of its misuse or abuse, as well as lack of data concerning whether the medicine could be abused if snorted or injected and its potential for liver toxicity, Reuters reported.

By withdrawing its application in the U.S., Nektar said it estimates 2020 cost savings of between $75 million and $125 million that would otherwise have been spent on the medicine's commercialization and post-approval studies.