By Kara Morris
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 FDA said the spray, which will be sold as Opvee, contains the drug nalmefene hydrochloride and will be available to Americans 12 years of age or older with a prescription.
“The agency continues to develop the FDA’s Overdose Prevention Framework and is taking practical steps that encourage harm reduction by supporting the development of new products to reverse overdoses,” said FDA Commissioner Dr. Robert Calif in an agency news release.
“Following the recent approval by the Food and Drug Administration of the first over-the-counter opioid reversal agent [Narcan]“The availability of nalmefene nasal spray puts a new option for reversing prescription opioids into the hands of communities, harm reduction groups and emergency responders,” Kalev added.
Indivior, which will make and sell Opvee in the future, said the spray will be available by October. Indivior bought Opiant Pharmaceuticals, which developed Opvee, in March.
“The Food and Drug Administration’s approval of Opvee represents a significant milestone in developing new treatment options to address today’s era of opioid overdoses driven by powerful synthetic opioids, such as fentanyl,” Mark Crossley, CEO of Endeavor, said in a company press release.
“Oppee is an emergency treatment for rapidly reversing respiratory depression caused 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 help save lives,” Crossley added.
Like its predecessor naloxone, which can be used either as a nasal spray or as an injection, nalmefene hydrochloride can reverse an overdose. The difference is that the naloxone wears off more quickly. This can avoid long-term withdrawal symptoms, even if the naloxone may need to be given a second time when it wears off, News agency mentioned.
Nalmefene, first approved in the 1990s as an injection but later withdrawn from the market due to a lack of sales, can reverse respiratory depression, sedation, and hypotension after an overdose. AP mentioned.
In a study of people who used opioids recreationally, adverse reactions included nasal discomfort, headache, nausea, dizziness, flushing, vomiting, anxiety, fatigue, nasal congestion and throat irritation, nasal pain, decreased appetite, flushed skin and sweating. excessive. the FDA said in its approval notice.
Medication use can also trigger a wide range of opioid withdrawal symptoms, from diarrhea to rapid heart rate, increased blood pressure, and more.
This is why some healthcare providers prefer a shorter-acting naloxone, with withdrawal symptoms lasting 30 to 40 minutes, even if it needs to be given more often.
“The risk of long-term withdrawal is very real and we’re trying to avoid it,” said Dr. Louis Nelson, of Rutgers University in New Jersey. AP. Nelson is an emergency physician and former advisor to the U.S. Food and Drug Administration on opioids.
“We’re not in a naloxone shortage where we need to use an alternative,” Nelson said. “We have a lot of them, and they’re doing really well.”
US health officials noted that these long-term effects were part of the goal of the new drug.
Dr. Nora Volkow, director of the US National Institute on Drug Abuse, told L.L.C AP.
According to the Food and Drug Administration, more than 103,000 Americans will die from drug overdoses in 2022.
About two-thirds of fatal overdoses in 2022 were linked to fentanyl and other synthetic opioids. Fentanyl stays in the body longer than heroin and other opioids AP He said.
The FDA recently approved Narcan nasal spray, which is the brand name for naloxone, to be sold without a prescription.
more information
The US Centers for Disease Control and Prevention provides more on drug overdoses and deaths.
Source: U.S. Food and Drug Administration press release, May 23, 2023; Individual, press release, May 23, 2023; News agency
