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FDA Approves New Nasal Spray To Reverse Fentanyl And Other Opioid Overdoses

By 05/22/2023 11:45 PMNo CommentsBy YidInfo Staff

A new, simple-to-use form of a drug to reverse overdoses brought on by fentanyl and other opioids fueling the country’s drug problem was approved by U.S. health regulators on Monday.

Opvee is comparable to naloxone, the life-saving medication employed for many years to stop overdoses of heroin, fentanyl, and prescription medications.

Both function by preventing the effects of opioids on the brain, which can help patients who have recently overdosed get their breathing and blood pressure back to normal.

The medicine nalmefene, licensed initially as an injectable in the middle of the 1990s but later taken off the market due to poor sales, was updated as Opvee, a nasal spray, and received approval from the Food and Medicine Administration. Naloxone is offered as an injectable and a nasal spray.

It’s not immediately apparent how the new medication will be used differently from naloxone, and some experts worry that its longer-lasting effects could have drawbacks.

For patients 12 and older, the drug will be prescribed and available.

Opvee and Narcan, the top-selling naloxone nasal spray, produced comparable recovery results in research supported by the federal government.

Opiant Pharmaceuticals, the producer of numerous drugs for opioid addiction and a competitor, recently bought Opvee. At the earliest, Indivior hopes to introduce Opvee in October.

Researchers in the pharmaceutical sector and the U.S. government recognized a new use for the substance as the opioid pandemic transitioned to fentanyl and other synthetic opioids.

Some patients might need doses of naloxone spread over several hours to completely reverse an overdose since fentanyl remains in the bloodstream longer than heroin and other opioids.

The National Institutes of Health’s scientists collaborated with pharmaceutical researchers to develop a nasal spray formulation of nalmefene that would revive users rapidly while preventing relapse.

More than $18 million in funds from the NIH, which also assisted in designing the trials, and the Biomedical Advanced Research and Development Authority of the United States government supported testing and development.

The National Institute on Drug Abuse’s Dr. Nora Volkow stated, “The whole goal of this was to have a medication that would last longer but also reach into the brain very rapidly.”

However, some analysts foresee potential drawbacks.

All opioid reversal medications have the unpleasant side effect of inducing severe withdrawal symptoms, including nausea, diarrhea, muscle cramping, and anxiety. These symptoms could persist for 30 to 40 minutes with naloxone.

According to Dr. Lewis Nelson of Rutgers University, these issues can persist with nalmefene for up to six hours, necessitating additional care and monitoring from medical specialists.

Dr. Nelson, an emergency care specialist and former opioid adviser to the FDA, stated that the risk of long-lasting withdrawal is quite natural and that it is something that should be avoided.

Nelson claimed that if naloxone wears off, it is simple to administer a second or third dose.



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