Titan Pharmaceuticals Gets FDA Clearance To Commence Opioid Disorder Study

The U.S. Food and Drug Administration (FDA) has cleared Titan Pharmaceuticals’ TTNP Investigational New Drug (IND) application for the Phase 1 study of its drug candidate Nalmefene.

The Phase 1 study will investigate six-month or longer subdermal formulation of nalmefene intended for the prevention of relapse following opioid detoxification in adults with Opioid Use Disorder (OUD).

Kate Beebe DeVarney, President and Chief Operating Officer of Titan, commented, "FDA clearance of the IND for our ProNeura®-based nalmefene implant marks an important milestone in developing a novel product that may help answer the call for long-term treatment options in addiction medicine. We are very grateful for the support we received from the National Institute for Drug Addiction, or NIDA, that enabled us to meet this objective.”

Titan Pharmaceuticals Shares are trading up 3 percent at $0.55 last check on Tuesday.