US WorldMeds Wins FDA Nod for First Non-Opioid to Treat Opioid Withdrawal Symptoms
Specialty drug company US WorldMeds’ Lucemyra (lofexidine hydrochloride) became the first non-opioid treatment for the management of opioid withdrawal symptoms among adults to receive US Food and Drug Administration (FDA) approval on Wednesday, according to an agency announcement.The oral tablet is intended to supplement long-term treatment plans for managing opioid use disorder by reducing the release of norepinephrine, which is believed to contribute towards opioid withdrawal symptoms. It is only approved for treatment lasting no more than 14 days.
US WorldMeds’ new drug application for Lucemyra was granted both priority review and fast track designation and was backed by FDA’s Psychopharmacologic Drugs Advisory Committee in an 11-to-1 vote in March.
Still, the company is required to conduct 15 postmarketing animal and human studies. “Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is currently approved, such as gradual opioid taper,” the agency concluded.
The approval comes as federal agencies, drug and device companies, as well as researchers and care professionals, among other stakeholders came together in recent years to take a comprehensive approach in the fight against the US opioid crisis.
FDA has previously indicated it intends to push for increased patient accessibility to more non-opioid treatments as part of these efforts, though challenges with securing health insurance coverage and reimbursement remain.
“We’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids,” said FDA Commissioner Scott Gottlieb. “We’re developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms.”