This photo provided by Indivior in May 2023 shows their Opvee. U.S. health regulators have approved the drug to reverse overdoses caused by fentanyl and other potent opioids.
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Indivior via AP
This photo provided by Indivior in May 2023 shows their Opvee. U.S. health regulators have approved the drug to reverse overdoses caused by fentanyl and other potent opioids.
Indivior via AP
WASHINGTON – U.S. health regulators on Monday approved an easy-to-use new version of a drug to reverse overdoses caused by fentanyl and other opioids fueling the nation’s drug crisis.
Opvee is similar to naloxone, the life-saving drug that has been used for decades to quickly combat heroin, fentanyl, and prescription painkillers. Both work by blocking the effects of opioids in the brain, which can restore normal breathing and blood pressure in people who have recently overdosed.
The Food and Drug Administration has approved Opvee, an update to the nasal spray of the drug nalmefene, which was first approved as an injectable in the mid-1990s but was subsequently removed from the market due to sales. low number. Naloxone comes in both nasal spray and injectable forms.
It remains unclear how the new drug will be used differently from naloxone, and some experts see potential downsides to its long-lasting effects. The drug will be available by prescription and approved for patients 12 years of age and older.
In federal government-funded studies, Opvee achieved similar recovery results as Narcan, the leading brand of naloxone nasal spray.
Opvee was developed by Opiant Pharmaceuticals, which was recently acquired by rival Indivior, the maker of several drugs to treat opioid addiction. Indivior is expected to launch Opvee in October at the earliest.
As the opioid pandemic shifts to fentanyl and other synthetic opioids, researchers in the pharmaceutical industry and the US government have seen a new role for the drug.
Because fentanyl stays in the body longer than heroin and other opioids, some people may need to take multiple doses of naloxone over several hours to completely reverse an overdose.
Scientists at the National Institutes of Health worked with pharmaceutical researchers on a nasal spray version of nalmefene that would rapidly resuscitate users, while protecting them from relapse. The trial and development was funded by more than $18 million in grants from the US government’s Biomedical Advanced Research and Development Agency and the NIH, which also helped design the studies.
Dr Nora Volkow, director of the National Institute on Drug Abuse, said: “The whole point of this is to create a drug that lasts longer but also gets into the brain very quickly.
However, some experts see potential downside.
A side effect of all opioid reversal medications is that they produce intense withdrawal symptoms including nausea, diarrhea, muscle cramps, and anxiety. With naloxone, those symptoms can last 30 to 40 minutes.
Dr Lewis Nelson of Rutgers University said those problems, which can last six hours or more with nalmefene, require further treatment and management by medical professionals.
“The risk of long-term withdrawal is very real, and we try to avoid it,” said Nelson, emergency physician and former FDA adviser on opioids.
Nelson says a second or third dose of naloxone can be easily given if it wears off.
“We are not so naloxone deficient that we have to use substitutes,” he said. “We have a lot and it works perfectly.”
The FDA approval comes as the number of drug overdose deaths rose slightly last year after two leaps during the pandemic. More than 109,000 fatal drug overdoses were recorded in 2022, according to the latest figures from the Centers for Disease Control and Prevention.
More than two-thirds of those deaths were linked to fentanyl and other synthetic opioids, which have largely replaced heroin and prescription opioids.
Naloxone has long been at the heart of government efforts to combat the overdose crisis at the federal and local levels. Police, firefighters and other first responders frequently carry medication. And officials in all 50 states have ordered pharmacists to sell or distribute the drug without a prescription to anyone who wants it.
In the latest federal effort, the FDA recently approved Narcan to be sold over-the-counter. This change will allow the new version of the drug to be stocked in grocery stores, vending machines and other retail locations. The nasal spray – which includes updated instructions for the general user – is expected to launch this summer. Emergent Biosolutions has yet to announce pricing for the over-the-counter version.
Indivior said it is still considering charging for its drug. It will compete in the same market as naloxone, where most buyers are local governments and community groups that distribute to first responders and those at risk of overdose. Indivior has told investors that Opvee could eventually generate $150 million to $250 million in annual revenue.
