By Cara Murez
TUESDAY, Might 23, 2023 (HealthDay Information) — The U.S. Meals and Drug Administration on Monday accredited a second nasal spray for reversing an opioid overdose.
To be offered as Opvee, the spray accommodates the treatment nalmefene hydrochloride and shall be out there to People 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 choice within the palms of communities, hurt discount teams and emergency responders,” Califf added.
Indivior, which can make and promote Opvee going ahead, mentioned the spray ought to be out there by October. Indivior purchased Opiant Prescription drugs, which developed Opvee, in March.
“Opvee’s FDA approval represents a major achievement within the improvement of latest therapy choices to handle at present’s period of opioid overdoses which are pushed by highly effective artificial opioids, reminiscent of fentanyl,” Indivior CEO Mark Crossley mentioned in an organization information launch.
“Opvee is an emergency therapy for the quick reversal of respiratory despair triggered by synthetic or natural opioids, together with fentanyl, and we’re dedicated to creating this novel rescue treatment broadly out there 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 rapidly. This may keep away from longer-lasting withdrawal signs, even when naloxone could should be administered a second time because it wears off, the Related Press reported.
Nalmefene, first accredited within the Nineties as an injection however later pulled from the marketplace for an absence of gross sales, can reverse respiratory despair, sedation and low blood strain following an overdose, the AP reported.
In a examine in individuals who used opioids recreationally, hostile 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 treatment also can set off a variety of opioid withdrawal signs, from diarrhea to speedy coronary heart price to elevated blood strain and extra.
That’s the reason some well being care suppliers want 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, informed 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 another,” Nelson mentioned. “We now have loads of it, and it really works completely effectively.”
Nonetheless, these long-lasting results had been a part of the purpose of the brand new treatment, U.S. well being officers famous.
“The entire intention of this was to have a medicine that will last more, but additionally attain into the mind very quickly,” Dr. Nora Volkow, director of the U.S. Nationwide Institute on Drug Abuse, informed the AP.
Greater than 103,000 People died in drug overdoses in 2022, in response to 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 not too long ago accredited Narcan nasal spray, a model identify of naloxone, to be offered over-the-counter.
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, Might 23, 2023; Indivior, information launch, Might 23, 2023; Related Press