September 9, 2019

FDA Postpones Opioid Approval Decision

According to an 8-K filing from Nektar Therapeutics to the U.S. Securities and Exchange Commission, the FDA has delayed a previously established drug-approval decision date for a new opioid. A letter from the FDA to Nektar Therapeutics states that the reason for postponing the decision process was not specific to the drug in question, as the FDA is currently considering a number of scientific policy issues relating to all opioids.

Nektar Therapeutics developed NKTR-181, also known as loxicodegol, an opioid for the treatment of chronic low-back pain without euphoric effects, intended to relieve pain with a reduced likelihood of addiction in patients who are new to opioid therapy. The FDA received the new drug application in May 2018 and targeted an August 29, 2019 date for finalizing their review of the application, in which they would approve or deny the drug.

However, the FDA informed Nektar Therapeutics in July that it was postponing the review process for the drug. This news came shortly after the FDA released a draft guidance document in June to describe the benefit-risk assessment framework the FDA uses when evaluating applications for opioid analgesic drugs.

The document was meant to inform drug developers of what kind of information should be included in a new drug application (NDA) for opioid medications, detailing various criteria around broader public health effects, risks and mitigation of risks related to misuse, abuse, opioid use disorder, overdose and more.

While the FDA is no longer accepting public commentary on this draft, they held a follow-up meeting on September 17th to discuss standards for future opioid analgesic approvals. The meeting was held to gather stakeholder input on the approval process for new opioids and how the FDA could best approach the matter. Along with opioid discussions, the meeting also focused on incentives for developing new, non-opioid pain medications.

For the last few years, the FDA has launched various initiatives targeting the opioid epidemic, including reassessing policies around risk evaluation and mitigation strategies (REMS) for opioid medications, tightening restrictions for transmucosal fentanyl products, proposing fixed-quantity blister packaging for certain opioids, and much more.

With these latest actions directly impacting the approval process, it is possible that significant change, though steady in delivery, could soon come.

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