Rapp proposes faster state approval of overdose reversal drugs
Rep. Kathy Rapp wants federally approved opioid overdose reversal medications in the hands of Pennsylvanians faster.
Rapp, R-Warren, is circulating a co-sponsorship memorandum for legislation she is drafting that will allow new products to be used in Pennsylvania more easily.
In 2014, the state Legislature enacted Act 139 which allowed law enforcement agencies, fire departments, and fire companies to give naloxone when someone is having an opioid-related drug overdose. That access was expanded to other overdose reversal drugs in 2022.
“My legislation will not require the use of additional opioid overdose reversal medications, nor mandate the issuance of a standing order or prescription for new medications,” Rapp said. “However, it will provide updated authorization for such use and provide continued good faith protections provided for in current law. As newer opioid overdose reversal medications are approved for use, we must remain proactive in providing more tools and access to combat overdose events.”
Nalaxone has been used more than 96,000 times in Pennsylvania since 2018, according to Rapp’s co-sponsorship memorandum. There are an average of 7,862 drug overdoses a year in the commonwealth since 2012, she said, while 13 state residents died each day from drug overdoses in 2023.
Rapp said she was moved to begin drafting her legislation after the U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. The agency approved the first nasal spray formulation of nalmefene in May 2023. Use of the new products would require a new standing order from the state similar to the 2014 standing order for naloxone.
The Food and Drug Administration endorsed Opvee, a nasal spray update of the drug nalmefene, which was first approved as an injection in the mid-1990s but later removed from the market due to low sales. Naloxone comes as both a nasal spray and injection. The drug will be available via prescription and is approved for patients 12 and older.
In studies funded by the federal government, Opvee achieved similar recovery results to Narcan, the leading brand of naloxone nasal spray. Opvee was developed by Opiant Pharmaceuticals, which was recently acquired by rival Indivior, maker of several medications for opioid addiction. Indivior expects to launch Opvee in October at the earliest, according to the Associated Press.
Because fentanyl stays in the body longer than heroin and other opioids, some people may require multiple doses of naloxone over several hours to fully reverse an overdose. Scientists at the National Institutes of Health worked with pharmaceutical researchers on a nasal spray version of nalmefene that would quickly resuscitate users, while also protecting them from relapse. Testing and development was funded by more than $18 million in grants from the U.S. government’s Biomedical Advanced Research and Development Authority and the NIH, which also helped design the studies.
“The whole aim of this was to have a medication that would last longer but also reach into the brain very rapidly,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse.
The Associated Press contributed to this report.