The Food and Drug Administration (FDA) has granted Fast Track designation to LYN-014 for the weekly treatment of opioid use disorder.
LYN-014 is an investigational oral, once-weekly, ultra-long-acting, extended-release levomethadone capsule designed to provide consistent target therapeutic levels over the course of an entire week. The Company believes that the once-weekly formulation may improve adherence for patients who struggle with daily visits to a methadone clinic.
The Company expects to initiate a phase 1 clinical trial this quarter. The FDA’s Fast Track designation allows for expedited review of therapies that are meant to treat serious or life-threatening conditions. Generally, the designation is granted to therapies that are expected to have an impact on factors such as survival and daily functioning.
“The opioid epidemic is a significant public health crisis that is having a devastating effect on millions of Americans, their families and their communities,” said Sandra Comer, PhD, Professor of Neurobiology in Psychiatry at Columbia University Vagelos College of Physicians and Surgeons, who will be an investigator for the trial. “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.”
Lyndra Therapeutics’ investigational oral, weekly opioid use disorder treatment LYN-014 granted Fast Track designation by FDA. News release. Lyndra Therapeutics. Accessed July 27, 2021. https://www.businesswire.com/news/home/20210727005453/en/Lyndra-Therapeutics%E2%80%99-Investigational-Oral-Weekly-Opioid-Use-Disorder-Treatment-LYN-014-Granted-Fast-Track-Designation-by-FDA.