Investigational Drug for Emergency Treatment of Opioid Overdose Receives FDA's Competitive Generic Therapy Designation

The FDA’s Office of Generic Drugs has granted Competitive Generic Therapy (CGT) designation to Purdue Pharma’s nalmefene hydrochloride (HCl) injection, an investigational opioid antagonist for the emergency treatment of known or suspected opioid overdose.¹

“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.¹ “We are committed to working with the agency’s generic products division to provide an injectable generic version of nalmefene HCl.”

The drug previously received the FDA’s recent Fast Track designation.¹

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 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.¹

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.¹

“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.”

Last month, Purdue Pharma settled litigation with the State of Oklahoma for $270 million and the establishment of the National Center for Addiction Studies and Treatment at Oklahoma State University (OSU) in Tulsa. A lawsuit filed by Oklahoma Attorney General Mike Hunter against Purdue Pharma and 3 other manufacturers of opioid pain medications in 2017 had claimed these companies utilized deceptive marketing campaigns over the previous decade, which helped fuel the state’s opioid epidemic.²

In settling the litigation, Purdue Pharma also agreed to not promote opioids in Oklahoma, including employing or contracting with sales representatives to health care providers in that state.²

“Purdue has a long history of working to address the problem of prescription opioid abuse and diversion,” said Landau, in a statement.² “We see this agreement with Oklahoma as an extension of our commitment to help drive solutions to the opioid addiction crisis."

References

• 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.
• Coppock K. Opioid Maker Agrees to Pay $270M for Addiction Treatment in Oklahoma. Pharmacy Times. https://www.pharmacytimes.com/news/opioid-mak-agrees-to-pay-270m-for-addiction-treatment-in-oklahoma/. Published March 26, 2019. Accessed April 25, 2019.