FDA approves new nasal spray to reverse drug overdoses

By Kara Murez

HealthDay reporter

TUESDAY, May 23, 2023 (HealthDay News) — The U.S. Food and Drug Administration on Monday approved a second nasal spray to reverse an opioid overdose.

The spray, sold as Opvee, contains the drug nalmefene hydrochloride and will be available by prescription for Americans ages 12 and older, the FDA said.

“The agency continues to advance the FDA Overdose Prevention Framework and is taking actionable steps that encourage harm reduction by supporting the development of new overdose reversal products,” said FDA Commissioner Dr. Robert Califf in a press release from the agency.

“On the heels of recent FDA approval of the first over-the-counter opioid reversal drug [Narcan]”The availability of nalmefene nasal spray puts a new option for prescription opioid reversal in the hands of communities, harm reduction groups and first responders,” Califf added.

Indivior, which will make and sell Opvee in the future, said the spray should be available in October. In March, Indivior bought Opiant Pharmaceuticals, which developed Opvee.

“Opvee’s FDA approval represents a major achievement in the development of new treatment options to address the current era of opioid overdose driven by potent synthetic opioids, such as fentanyl,” said Mark Crossley, CEO of Indivior, in a statement. company press release.

“Opvee is an emergency treatment for the rapid reversal of respiratory depression caused by natural or synthetic opioids, including fentanyl, and we are committed to making this novel rescue medication widely available to those who need it most to help save lives,” added Crossley.

Like its predecessor naloxone, which can be used as a nasal spray or injection, nalmefene hydrochloride can reverse an overdose. The difference is that naloxone wears off faster. This can prevent prolonged withdrawal symptoms, even if naloxone has to be administered a second time as it wears off. Associated Press reported.

Nalmefene, first approved in the 1990s as an injection but later withdrawn from the market due to lack of sales, can reverse respiratory depression, sedation and low blood pressure following an overdose. AP reported.

In a study of people using opioids recreationally, side effects included nasal discomfort, headache, nausea, dizziness, hot flashes, vomiting, anxiety, fatigue, nasal congestion and throat irritation, nasal pain, decreased appetite, skin redness, and excessive sweating. , the FDA said in its approval notice.

Taking the medication can also cause a wide variety of opioid withdrawal symptoms, from diarrhea to rapid heartbeat to elevated blood pressure and more.

Therefore, some health care providers prefer shorter-acting naloxone, with withdrawal symptoms lasting 30 to 40 minutes, even if it has to be given more than once.

“The risk of prolonged withdrawal is very real and we try to avoid it,” Dr. Lewis Nelson of Rutgers University in New Jersey at the AP. Nelson is an emergency medicine physician and a former FDA consultant on opioids.

“We’re not suffering from a naloxone deficiency that requires us to use an alternative,” Nelson said. “We’ve had enough of it and it works perfectly.”

Still, those long-lasting effects were part of the point of the new medication, U.S. health officials noted.

“The whole point of this was to have a drug that would work longer, but also get to the brain very quickly,” Dr. Nora Volkow, director of the US National Institute on Drug Abuse AP.

According to the FDA, more than 103,000 Americans will die from drug overdoses in 2022.

About two-thirds of fatal overdoses in 2022 were related to fentanyl and other synthetic opioids. Fentanyl lingers in the body longer than heroin and other opioids AP said.

The FDA recently approved Narcan Nasal Spray, a brand name of naloxone, for sale over the counter.

More information

The U.S. Centers for Disease Control and Prevention has more information on overdoses and deaths.

SOURCE: U.S. Food and Drug Administration press release, May 23, 2023; Individual, press release, May 23, 2023; Associated Press