FDA Approves New Nasal Spray to Reverse Overdoses

By Cara Murez 

HealthDay Reporter

TUESDAY, Could 23, 2023 (HealthDay Information) — The U.S. Meals and Drug Administration on Monday authorized a second nasal spray for reversing an opioid overdose.

To be bought as Opvee, the spray comprises the remedy nalmefene hydrochloride and will probably be accessible to Individuals aged 12 and older with a prescription, the FDA mentioned.

“The company continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage hurt discount by supporting the event of novel overdose reversal merchandise,” FDA Commissioner Dr. Robert Califf mentioned in an company information launch.

“On the heels of the FDA’s current approval of the primary over-the-counter opioid reversal agent [Narcan], the supply of nalmefene nasal spray locations a brand new prescription opioid reversal possibility within the fingers of communities, hurt discount teams and emergency responders,” Califf added.
 

Indivior, which is able to make and promote Opvee going ahead, mentioned the spray ought to be accessible by October. Indivior purchased Opiant Prescription drugs, which developed Opvee, in March.

“Opvee’s FDA approval represents a major achievement within the growth of recent remedy choices to deal with at present’s period of opioid overdoses which are pushed by highly effective artificial opioids, similar to fentanyl,” Indivior CEO Mark Crossley mentioned in an organization information launch.

“Opvee is an emergency remedy for the quick reversal of respiratory despair triggered by man-made or natural opioids, together with fentanyl, and we’re dedicated to creating this novel rescue remedy extensively accessible to those that want it most to assist save lives,” Crossley added.

Like its predecessor naloxone, which can be utilized as both a nasal spray or an injection, nalmefene hydrochloride can reverse an overdose. The distinction is that naloxone wears off extra shortly. This will keep away from longer-lasting withdrawal signs, even when naloxone could have to be administered a second time because it wears off, the Related Press reported.

Nalmefene, first authorized within the 1990s as an injection however later pulled from the marketplace for an absence of gross sales, can reverse respiratory despair, sedation and low blood stress following an overdose, the AP reported.

In a examine in individuals who used opioids recreationally, antagonistic reactions included nasal discomfort, headache, nausea, dizziness, sizzling flush, vomiting, anxiousness, fatigue, nasal congestion and throat irritation, ache within the nostril, decreased urge for food, pores and skin redness and extreme sweating, the FDA mentioned in its approval discover.
 

Utilizing the remedy may also set off a variety of opioid withdrawal signs, from diarrhea to speedy coronary heart charge to elevated blood stress and extra.
 

That’s the reason some well being care suppliers desire the shorter-lasting naloxone, with withdrawal signs that final 30 to 40 minutes, even when it must be given greater than as soon as.

“The chance of long-lasting withdrawal may be very actual and we attempt to keep away from it,” Dr. Lewis Nelson, of Rutgers College in New Jersey, advised the AP. Nelson is an emergency drugs doctor and a former FDA adviser on opioids.

“We’re not affected by a naloxone scarcity the place we have to use an alternate,” Nelson mentioned. “We have now loads of it, and it really works completely properly.”

Nonetheless, these long-lasting results had been a part of the purpose of the brand new remedy, U.S. well being officers famous.

“The entire goal of this was to have a medicine that might last more, but additionally attain into the mind very quickly,” Dr. Nora Volkow, director of the U.S. Nationwide Institute on Drug Abuse, advised the AP.

Greater than 103,000 Individuals died in drug overdoses in 2022, in keeping with the FDA.

About two-thirds of deadly overdoses in 2022 had been linked to fentanyl and different artificial opioids. Fentanyl lingers within the physique longer than heroin and different opioids, the AP mentioned.

The FDA lately authorized Narcan nasal spray, a model identify of naloxone, to be bought over-the-counter.

Extra info

The U.S. Facilities for Illness Management and Prevention has extra on drug overdoses and deaths.

SOURCE: U.S. Meals and Drug Administration, information launch, Could 23, 2023; Indivior, information launch, Could 23, 2023; Related Press