FDA approves new nasal spray to reverse overdose

Written by Cara Murez

Health Day reporter

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

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

“The agency continues to advance the FDA’s overdose prevention framework and take actionable steps to reduce harm by supporting the development of new overdose reversal products,” FDA Commissioner Dr. Robert Califf said in an agency news release.

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

Indivior, which will manufacture and sell Opvee in the future, said the spray should be available by October. Indivior bought Opiant Pharmaceuticals, the developer of Opvee, in March.

“The FDA approval of Opvee is a significant achievement in the development of new treatment options for today’s era of opioid overdose caused by powerful synthetic opioids such as fentanyl,” said Mark Crossley, CEO of Indivior, in the company’s press release.

“Opvee is an emergency treatment for the rapid reversal of respiratory depression induced by natural or synthetic opioids, including fentanyl, and we are committed to making this new rescue drug widely available to those who need it most to save lives,” he said. 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 avoids long-lasting withdrawal symptoms, even if the naloxone has to be administered a second time when it wears off. Associated Press was reported.

Nalmefene, first approved as an injection in the 1990s but later withdrawn from the market due to lack of sales, can reverse respiratory depression, sedation and low blood pressure following overdose.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

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

Using the drug can also trigger a wide range of opioid withdrawal symptoms, from diarrhea to rapid heartbeat to increased blood pressure and more.

For this reason, some health care providers prefer the shorter-acting naloxone, which has withdrawal symptoms that last 30 to 40 minutes, even if multiple injections are required.

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

“We don’t have a naloxone shortage where we have to use an alternative,” Nelson said. “There’s plenty of it, and it works perfectly.”

Still, those long-lasting effects were part of the new drug’s point, US health officials noted.

“The whole point was to have a drug that lasts longer but gets into the brain very quickly,” said Dr. Nora Volkow, director of the US National Institute on Drug Abuse. AP.

More than 103,000 Americans will die of drug overdoses in 2022, according to the FDA.

In 2022, about two-thirds of fatal overdoses involved fentanyl and other synthetic opioids. Fentanyl stays in the body longer than heroin and other opioids, a AP said.

The FDA recently approved Narcan nasal spray, the over-the-counter brand name for naloxone.

More information

The US Centers for Disease Control and Prevention is more concerned with drug overdoses and deaths.

SOURCE: US Food and Drug Administration, press release, May 23, 2023; Indivior, press release, 23 May 2023; Associated Press