Lyndra Therapeutics’ Weekly OUD Treatment Gets Fast Track Designation from FDA

Lyndra Therapeutics, a Watertown, Massachusetts-based clinical-stage biotech firm, announced this week that its oral, extended-release medication for treatment of opioid use disorder has received a Fast Track designation by the FDA.

The medication, LYN-014, is a levomethadone capsule delivered weekly, which provide a more sustainable treatment regiment for OUD patients by reducing the frequency of their trips to methadone clinics. The Fast Track designation facilitates development and expedites review of new drugs to treat serious conditions and address unmet medical needs. A Phase I clinical trial for LYN-014 is now slated to begin this quarter.

“Many of the treatments and interventions in our armamentarium were developed before the widespread availability of highly potent, illicit fentanyl, so it is vital that we develop new treatments and approaches for people struggling with opioid use disorder,” Sandra Comer, PhD, professor of Neurobiology in psychiatry at Columbia University Vagelos College of Physicians and Surgeons, who will be an investigator for the clinical trial, said in a news release.

LYN-014 is designed to “provide extended gastric residence, controlled, steady drug release, and timely passage into the gastrointestinal tract,” according to the release. While levomethadone is approved for use as a daily treatment for pain management and opioid maintenance therapy in Europe, it has not been approved in the U.S. Lyndra’s formulation was granted Investigational New Drug status by FDA in April.