FDA Grants Competitive Generic Therapy Designation to Investigational Drug for Emergency Treatment of Opioid Overdose

An investigational opioid antagonist for the emergency treatment of known or suspected opioid overdose has been granted Competitive Generic Therapy (CGT) designation by the FDA’s Office of Generic Drugs. The designation was received by Purdue Pharma for its nalmefene hydrochloride (HCl) injection.

The drug previously received the FDA’s recent Fast Track designation.

The CGT designation allows for expedited review of generic versions of medications with inadequate generic competition, and is intended to help facilitate the timely market entry of generic drugs.²The Fast Track and CGT designations are timely, as overdose deaths due to opioids continue to rise, driven by abuse of extremely potent and long-lasting synthetic opioid agonists, particularly illicitly manufactured fentanyl and its analogues.

“We are pleased the FDA has granted nalmefene HCl injection CGT designation, a decision that supports our common interest in making this important treatment option available as broadly and quickly as possible,” said Richard Fanelli, PhD, vice president, Regulatory Affairs, Imbrium Therapeutics L.P., a subsidiary of Purdue, in a prepared statement. “We are committed to working with the agency’s generic products division to provide an injectable generic version of nalmefene HCl.”

According to Purdue Pharma, Nalmefene HCl has a longer duration of action than naloxone, another opioid antagonist currently approved for emergency treatment of known or suspected opioid overdose. 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. However, there is no guarantee that nalmefene HCl injection, an investigational agent, will successfully complete development or gain FDA approval.

In a statement, Craig Landau, MD, president and CEO, Purdue Pharma, said the company and its subsidiaries will not profit from any future sales of nalmefene HCl injection, if it is approved by the FDA for market.

“Purdue recognizes the immediate and critical need to treat potential fatal overdoses associated with opioid abuse and addiction,” said Landau. “We are encouraged by 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.”

Reference

FDA Grants Competitive Generic Therapy (CGT) Designation to Purdue Pharma’s Investigational Nalmefene HCl Injection for the Emergency Treatment of Known or Suspected Opioid Overdose [news release]. April 24, 2019; Stamford, CT: Purdue Pharma.https://www.businesswire.com/news/home/20190424005220/en. Accessed April 25, 2019.