FDA finalizes guidance on novel medicines to treat opioid use disorder

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The U.S. Food and Drug Administration issued its finalized guidance for drug companies hoping to create new medicines to treat opioid use disorder.

Previously, the FDA had opened its guidance up for public comment. That public comment period ended in late August. The finalized guidance addresses those public comments.

According to FDA Commissioner Stephen Hahn, a rise in opioid deaths, especially in synthetic opioids, fuels a need to find new ways to treat opioid use disorder.

“One way we are doing so is through exploring new ways to measure effectiveness of treatments, as we seek to help individuals with opioid use disorder (OUD),” Hahn said in a statement. “We recognize that there’s great interest in developing new treatment options that result in meaningful outcomes. We know from research that treatment for OUD with both prescription drugs – including buprenorphine, methadone, and naltrexone – and relevant social, medical, and psychological services is a highly effective treatment.”

The guidance outlines what patients certain drugs can be used. For instance, drugs that have opioid agonist activity can be used in patients currently using opioids. Still, those with antagonist activity can only be used in patients who have discontinued opioid use because of the risk of severe withdrawal symptoms. The guidance also outlines what kinds of clinical trials should be used and what the endpoints of those trials should look like.

“The FDA is committed to assisting in the development of high-quality, effective medications and encouraging health care professionals to ensure patients with OUD are offered an adequate chance to benefit from these therapies,” Hahn said.

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