FDA clears Titan Pharma IND for nalmefene implant

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The FDA has cleared Titan Pharmaceuticals’ (NASDAQ:TTNP) investigational new drug application for a Phase 1 study of its six-month or longer subdermal formulation of nalmefene, an opioid antagonist, intended for the prevention of relapse following opioid detoxification in adults with opioid use disorder.

In a statement, Kate Beebe DeVarney, Ph.D., president and COO of Titan, said FDA clearance of the IND for Titan’s 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,” she added.

The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes.