The U.S. Food and Drug Administration has approved the first nonopioid treatment to help adults manage opioid withdrawal symptoms as the agency looks to continue to encourage the development of therapies to help patients suffering from addiction.
The FDA granted the approval of Lucemyra to Louisville, Ky.-based pharmaceutical company US WorldMeds LLC, the agency said Wednesday. The company also develops products for patients with Parkinson’s disease, malignant hyperthermia and other medical conditions.
“We’re developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms,” FDA Commissioner
said in prepared remarks. “We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction.”
The approval of Lucemyra comes as more than 20 states and hundreds of cities and counties have filed lawsuits against opioid-painkiller makers and distributors, alleging they fueled an addiction crisis by misrepresenting the risks of the drugs. Several companies have denied such allegations or affirmed their commitments to safe and responsible use of prescription medications. President Donald Trump declared the opioid crisis a public-health emergency last year, a designation that has since been extended but that falls short of a national-emergency declaration.
The treatment, which isn’t designed to be a treatment for opioid addiction, is expected to be commercially available in the U.S. in August.
Lucemyra, generically called lofexidine hydrochloride, is an oral treatment that helps reduce the release of norepinephrine, which is believed to play a role in the development of withdrawal symptoms such as anxiety, agitation, sleep problems, muscle aches, and nausea, the company and agency said. Symptoms can develop after stopping or reducing the use of opioids.
While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them, the company and the FDA said. Lucemyra is only approved for treatment for up to 14 days.
Common side effects from Lucemyra include low blood pressure, slow heart rate, sleepiness, sedation and dizziness. Lucemyra was also associated with a few cases of fainting and can increase the risk of abnormal heart rhythms. When Lucemyra is stopped, patients can experience a marked increase in blood pressure, the FDA said.
Lucemyra was tested in two clinical trials. However, the FDA is requiring 15 postmarketing studies, including both animal and human studies to support longer-term use and use in children.
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