New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval

WASHINGTON, D.C. (AP) - U.S. regulators approved on Monday a new version of an easy-to use medication that reverses overdoses due to fentanyl or other opioids fueling the drug crisis in this country.

Opvee works similarly to naloxone. This life-saving drug has been used to counter heroin overdoses, as well as those caused by fentanyl, prescription painkillers, and other opioids. Both drugs work by blocking opioids' effects in the brain. This can restore normal blood pressure and breathing in those who have overdosed.

Opvee is a nasal spray version of nalmefene. It was originally approved for injections in mid-1990s, but it was later taken off the market because of low sales. Naloxone is available as a nasal spray or injection.

Some experts believe that the longer-acting effects of this new drug could have negative side effects. The drug is available by prescription only and approved for patients aged 12 and over.

Opvee, the leading brand naloxone nasal sprayed, achieved similar results in studies funded by federal government.

Opvee is a drug developed by Opiant Pharmaceuticals. Indivior recently acquired Opiant Pharmaceuticals. Indivior manufactures several drugs for opioid addiction. Indivior plans to launch Opvee as early as October.

Researchers in the pharmaceutical industry, as well as the U.S. Government, saw that fentanyl had a new purpose.

Some people may need to take multiple doses of Naloxone for several hours in order to reverse an overdose. This is because fentanyl remains in the body much longer than heroin or other opioids.

Scientists from the National Institutes of Health collaborated with pharmaceutical researchers to develop a nasal spray form of nalmefene, which would help resuscitate patients quickly and protect them against relapse. The Biomedical Advance Research and Development Authority of the U.S. Government and the NIH funded the testing and development with more than 18 million dollars in grants.

The National Institute on Drug Abuse's Dr. Nora Volkow said, "The goal was to develop a drug that would not only last longer, but also penetrate the brain quickly."

Some experts still see possible downsides.

All opioid reversal medications can cause intense withdrawal symptoms, including nausea, diarrhea and muscle cramps. These symptoms may last up to 40 minutes with naloxone.

Dr. Lewis Nelson, Rutgers University, says that these problems can last up to six hours with nalmefene and require extra management and treatment by health professionals.

Nelson, a former FDA adviser on opioids and emergency medicine physician, said: "The risk of long lasting withdrawal is real, and we do our best to avoid it."

Nelson said that if the naloxone wears off, it is easy to administer a second dose or a third.

He said, 'We don't have a shortage of naloxone where we would need to use a substitute.' We have plenty and it works well.

FDA approved the drug after drug overdoses increased slightly in deaths last year, following two large jumps during pandemic. According to the Centers for Disease Control and Prevention, more than 109,000 deaths from overdoses will be recorded by 2022.

Over two-thirds were linked to fentanyl, and other synthetic opioids that have replaced heroin and prescription painkillers.

Naloxone is a drug that has been used by the government to combat the opioid crisis on a federal and local level for many years. The drug is carried by police, firefighters and first responders. Officials in all 50 states ordered pharmacists to sell the drug to anyone without a prescription.

The FDA has recently approved Narcan for sale over-the-counter. This change will enable the new version to be sold in supermarkets, vending machine and other retail locations. The nasal spray, which comes with updated instructions for regular use, is expected to be launched this summer. Emergent Biosolutions is yet to announce a price on the over-the counter version.

Indivior has not yet decided how much to charge for the drug. It will be competing in the same market with naloxone where local governments and groups distribute it to first responders, and people at risk of an overdose. Indivior told investors that Opvee would eventually be able to generate sales of between $150 million and $250 million.

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