American Society of Addiciton Medicine

FDA Approves First Non-Opioid Drug for the Management of Opioid Withdrawal

On May 16, the Food and Drug Administration (FDA) announced its approval Lucemyra, the first non-opioid treatment for management of opioid withdrawal symptoms.

Lucemyra (lofexidine hydrochloride) reduces the release of norepinephrine and can be used to lessen the severity of withdrawal symptoms that may occur after the discontinuation of opioid use. The drug is only approved for use up to 14 days and may ameliorate symptoms of withdrawal but may not completely stop them. In their announcement, the FDA emphasized that Lucemyra should not be considered treatment for opioid use disorder (OUD) and should be a component of a comprehensive, long-term treatment plan.

In an article published on in-PharmaTechnologist.com, Dr. Yngvild Olsen, MD, DFASAM, Board Secretary of ASAM and Medical Director of the Institutes for Behavioral Resources Inc, said, “the FDA-approval of Lucemyra adds another tool to the toolbox for patients and practitioners considering opioid withdrawal management. ASAM looks forward to collaborating with the FDA and other government agencies to promote advances in and increased access to therapies that can increase treatment options for patients with addiction. This would include research on novel approaches to managing opioid withdrawal.”