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 an opioid overdose.
Sold under the name Opvee, the spray contains the drug nalmefene hydrochloride and will be available to Americans ages 12 and older with a prescription, the FDA said.
“The agency continues to advance the FDA’s overdose prevention framework and take concrete steps that encourage harm reduction by supporting the development of new overdose reversal products,” the FDA commissioner said. , Dr. Robert Califf, in an agency press release.
“On the heels of 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,” Califf added.
Indivior, which will manufacture and sell Opvee in the future, said the spray should be available by October. Indivior bought Opiant Pharmaceuticals, which developed Opvee, in March.
“The FDA approval of Opvee represents a significant achievement in the development of new treatment options to address the current era of opioid overdoses that are caused by potent synthetic opioids, such as fentanyl,” Indivior CEO Mark Crossley said in a company press release.
“Opvee is an emergency treatment for the rapid reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl, and we are committed to making this new rescue medication widely available to those who need it most. needed to help save lives,” Crossley added.
Like its predecessor, naloxone, which can be used as a nasal spray or injection, nalmefene hydrochloride can reverse an overdose. The difference is that the naloxone wears off faster. This may prevent longer lasting withdrawal symptoms, although the naloxone may need to be given a second time when it wears off, the Associated Press reported.
Nalmefene, first approved in the 1990s as an injection but later withdrawn from the market due to a lack of sales, can reverse respiratory depression, sedation and low blood pressure following an overdose. THE PA reported.
In a study of people using opioids recreationally, adverse effects included nasal discomfort, headache, nausea, dizziness, flushing, vomiting, anxiety, fatigue , nasal congestion and throat irritation, nose pain, loss of appetite, redness of the skin and excessive sweating. , the FDA said in its notice of approval.
Using the drug can also trigger a wide range of opioid withdrawal symptoms, from diarrhea to racing heartbeat to increased blood pressure and more.
This is why some health care providers prefer short-acting naloxone, with withdrawal symptoms lasting 30 to 40 minutes, even if it has to be given more than once.
“The risk of long-term withdrawal is very real and we are trying to avoid it,” said Dr Lewis Nelson, of Rutgers University in New Jersey. PA. Nelson is an emergency physician and former FDA advisor on opioids.
“We don’t have a naloxone shortage where we have to use an alternative,” Nelson said. “We have a lot of that, and it works perfectly well.”
Still, those lasting effects were part of the new drug’s purpose, U.S. health officials noted.
“The goal was to have a drug that would last longer, but also get to the brain very quickly,” said Dr. Nora Volkow, director of the US National Institute on Drug Abuse. PA.
More than 103,000 Americans died from drug overdoses in 2022, according to the FDA.
About two-thirds of fatal overdoses in 2022 were linked to fentanyl and other synthetic opioids. Fentanyl persists in the body longer than heroin and other opioids, PA said.
The FDA recently approved Narcan nasal spray, a brand name for naloxone, to be sold over the counter.
The US Centers for Disease Control and Prevention has more on drug overdoses and deaths.
SOURCE: US Food and Drug Administration, press release, May 23, 2023; Individual, press release, May 23, 2023; Associated Press