The FDA has approved a new nasal spray for reversing opioid overdose, especially fentanyl overdose.
The spray, called Opvee, is a new delivery vehicle for nalmefene. Nalmefene is a drug that was approved in the 1990s in the form of an injection but was withdrawn from the market due to poor sales. The Associated Press reported. It has been approved for use in patients 12 years and older as an emergency medication for people suffering from an opioid overdose.
The approval “puts a new prescription opioid reversal option in the hands of communities, harm reduction groups, and emergency responders,” said FDA Commissioner Robert M. Calif. Said. The news comes months after regulators approved the regulation. over the counter A version of Naloxone Nasal Spray, also known as Narcan.
A newly approved spray called “Opvee” is approved for patients over the age of 12 who suffer from an opioid overdose.
Both drugs work by essentially blocking the effects of opioids in the brain and restoring the victim’s breathing and blood pressure.
In clinical trials, nalmefene nasal spray was comparable in performance to Narcan. FiercePharma reportedThis prompted the drug maker, Indibiol, to apply for approval and secure Fast Track designation. Indivier also makes the opioid drug Saboxson.
Nalmefene Against Narkan: After two big spikes during the pandemic, the number of deaths from opioid overdoses in the United States will rise slightly again in 2022, topping 109,000 deaths, The Associated Press reported.
Fentanyl and other synthetic opioids now account for the majority of overdose deaths, prompting a new view of nalmefene. Fentanyl stays in the body longer than heroin and other opioids, meaning multiple doses of Narcan may be required to reverse an overdose. So researchers looked to develop overdose sprays that are better suited to synthetic opioids.
“The whole goal of this project was to develop a drug that had a long duration and also reached the brain very quickly,” Nora Volkow, director of the National Institute on Drug Abuse, told The Associated Press. Told.
However, opioid antagonists can have particularly troublesome side effects, including rapid withdrawal symptoms such as nausea, seizures, and anxiety. Obviously, saving lives is more important than withdrawal, but doctors may be reluctant to use this treatment instead of Narcan, especially if symptoms persist.
Fentanyl stays in the body longer than heroin and other opioids, meaning multiple doses of Narcan may be required. So the researchers developed his Opvee, which has the potential to be better suited to synthetic opioids.
Narcan can cause these effects to last as long as 30 minutes, but nalmefene is longer lasting, so the discomfort can last six hours or more, Rutgers University emergency physician Louis Nelson told The Associated Press. rice field. That means additional treatment by already strained health care providers.
“The risk of long-term withdrawal is very real and we try to avoid it,” Nelson, who once advised the FDA on opioids, told the Associated Press. “We are not suffering from a naloxone shortage that requires us to use alternatives. We have plenty of it and it works perfectly.”
Indivior plans to deploy Opvee as early as October.
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