The U.S. Food and Drug Administration approved US WorldMeds, LLC's Lucemyra as the first non-opioid treatment for managing opioid withdrawal symptoms in adults.
Lucemyra, or lofexidine hydrochloride, is only approved for treatment for up to 14 days and may lessen the severity of withdrawal symptoms but not completely prevent them, according to the U.S. regulator.
The FDA said Lucemyra is not a treatment for opioid use disorder but can be used as part of a broader long-term treatment plan for managing it.
The privately held Louisville, Ky.-based company's therapy had earlier received a 11-1 favorable vote from the FDA's Psychopharmacologic Drugs Advisory Committee, for mitigating opioid withdrawal symptoms. The drug had already secured a priority review and fast-track designation from the regulator.
The FDA said it is "developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms."
Opioid withdrawal includes symptoms such as anxiety, agitation, sleep problems and drug craving, among others, which occur after stopping or reducing the use of opioids in anyone with physical dependence on opioids.
Lucemyra works by reducing the release of norepinephrine — a chemical released from neurons in the sympathetic nervous system and believed to play a role in many of the symptoms of opioid withdrawal.
The FDA said it requires 15 post-marketing studies, including both animal and human studies, additional animal safety studies to support longer-term use and for use in children.
