First Non-Opioid Drug Approved for Managing Opioid Withdrawal Symptoms

Robert F. Bukaty  AP

"Today's approval represents the first FDA-approved non-opioid treatment for the management of opioid withdrawal symptoms and provides a new option that allows providers to work with patients to select the treatment best suited to an individual's needs", said Sharon Hertz, director of the Division of Anesthesia, Analgesia and Addiction Products at the FDA.

Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal.

The national opioid epidemic has put a spotlight on the need for more treatments for pain, withdrawal symptoms and addiction. The agency also pointed out that Lucemyra is not meant to treat opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.

Lucemyra, an oral selective alpha 2-adrenergic receptor agonist, limits the body's output of norepinephrine, the hormone believed to play a role in symptoms of opioid withdrawal, the FDA said.


Patients' fear of experiencing withdrawal often hinders them from seeking treatment, and those who do seek help may relapse due to ongoing symptoms, Dr. Gottlieb added. Lucemyra is now only approved for no more than 14 days of treatment. At present the new drug has been granted Priority Review and Fast Track approval. In its announcement, US WorldMeds explained that Lucemyra "suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal". Lucemyra's side effects could include hypotension, bradycardia, sleepiness, and dizziness. It is not approved as a treatment for opioid use disorder. Also, the patient may be more sensitive to the effects of lower amounts of opioids, so they could overdose or die if they go back to using opioids to the extent that they did before they stopped using opioids. Patients can experience any combination of these symptoms after ceasing opioid use.

Patients with chronic pain can attend the FDA's "Patient-Focused Drug Development for Chronic Pain" meeting on July 9 from 10 a.m.to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online.

The safety and efficacy have not been established in children or adolescents 17 years of age and younger. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly. The FDA mandated an additional 15 post-market studies of the drug, including more pre-clinical safety trials that will be necessary for label expansions.

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