The U.S. Food & Drug Administration’s Office of Generic Drugs has granted Purdue Pharma LP a competitive generic therapy designation for its nalmefene hydrochloride injection in the treatment of opioid overdose.
The new designation follows last month’s FDA’s Fast Track designation for nalmefene HCl. According to Stamford-based Purdue Pharma, nalmefene HCl has a longer duration of action than naloxone, a widely used treatment for known or suspected opioid overdoses. If approved, the duration of effect of nalmefene HCl injection has the potential to serve as an important alternative for the treatment of opioid overdose. There is no guarantee that nalmefene HCl injection, an investigational agent, will successfully complete development or gain FDA approval.
Craig Landau, president and CEO of Purdue Pharma, noted that the company and its subsidiaries would not take profits from nalmefene HCI sales if the treatment receives FDA approval for retail distribution.
“Purdue recognizes the immediate and critical need to treat potential fatal overdoses associated with opioid abuse and addiction,” Landau said. “We are encouraged by the FDA’s recent regulatory designations for nalmefene HCI, as we believe they acknowledge the urgent need for new and potentially more effective medications to address this public health emergency. Our company is committed to making this potentially life-saving treatment available as broadly and quickly as possible.”