FDA Approves New Nasal Spray to Reverse Overdoses

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By Cara Murez 

HealthDay Reporter

TUESDAY, May 23, 2023 (HealthDay News) -- The U.S. Food and Drug Administration connected Monday approved a 2nd nasal spray for reversing an opioid overdose.

To beryllium sold arsenic Opvee, nan spray contains nan medicine nalmefene hydrochloride and will beryllium disposable to Americans aged 12 and older pinch a prescription, nan FDA said.

"The agency continues to beforehand nan FDA Overdose Prevention Framework and return actionable steps that promote harm simplification by supporting nan improvement of caller overdose reversal products," FDA Commissioner Dr. Robert Califf said successful an agency news release.

"On nan heels of nan FDA's caller support of nan first over-the-counter opioid reversal supplier [Narcan], nan readiness of nalmefene nasal spray places a caller medicine opioid reversal action successful nan hands of communities, harm simplification groups and emergency responders," Califf added.

Indivior, which will make and waste Opvee going forward, said nan spray should beryllium disposable by October. Indivior bought Opiant Pharmaceuticals, which developed Opvee, successful March.

“Opvee’s FDA support represents a important accomplishment successful nan improvement of caller curen options to reside today’s era of opioid overdoses that are driven by powerful synthetic opioids, specified arsenic fentanyl,” Indivior CEO Mark Crossley said successful a institution news release.

“Opvee is an emergency curen for nan accelerated reversal of respiratory slump triggered by earthy aliases synthetic opioids, including fentanyl, and we are committed to making this caller rescue medicine wide disposable to those who request it astir to thief prevention lives,” Crossley added.

Like its predecessor naloxone, which tin beryllium utilized arsenic either a nasal spray aliases an injection, nalmefene hydrochloride tin reverse an overdose. The quality is that naloxone wears disconnected much quickly. This tin debar longer-lasting withdrawal symptoms, moreover if naloxone whitethorn request to beryllium administered a 2nd clip arsenic it wears off, nan Associated Press reported.

Nalmefene, first approved successful nan 1990s arsenic an injection but later pulled from nan marketplace for a deficiency of sales, tin reverse respiratory depression, sedation and debased humor unit pursuing an overdose, nan AP reported.

In a study successful group who utilized opioids recreationally, adverse reactions included nasal discomfort, headache, nausea, dizziness, basking flush, vomiting, anxiety, fatigue, nasal congestion and pharynx irritation, symptom successful nan nose, decreased appetite, tegument redness and excessive sweating, nan FDA said successful its support notice.

Using nan medicine tin besides trigger a wide scope of opioid withdrawal symptoms, from diarrhea to accelerated bosom complaint to accrued humor unit and more.

That is why immoderate wellness attraction providers for illustration nan shorter-lasting naloxone, pinch withdrawal symptoms that past 30 to 40 minutes, moreover if it needs to beryllium fixed much than once.

“The consequence of long-lasting withdrawal is very existent and we effort to debar it,” Dr. Lewis Nelson, of Rutgers University successful New Jersey, told nan AP. Nelson is an emergency medicine expert and a erstwhile FDA advisor connected opioids.

“We’re not suffering from a naloxone shortage wherever we request to usage an alternative,” Nelson said. “We person plentifulness of it, and it useful perfectly well.”

Still, those long-lasting effects were portion of nan constituent of nan caller medication, U.S. wellness officials noted.

“The full purpose of this was to person a medicine that would past longer, but besides scope into nan encephalon very rapidly,” Dr. Nora Volkow, head of nan U.S. National Institute connected Drug Abuse, told nan AP.

More than 103,000 Americans died successful supplier overdoses successful 2022, according to nan FDA.

About two-thirds of fatal overdoses successful 2022 were linked to fentanyl and different synthetic opioids. Fentanyl lingers successful nan assemblage longer than heroin and different opioids, nan AP said.

The FDA precocious approved Narcan nasal spray, a marque sanction of naloxone, to beryllium sold over-the-counter.

More information

The U.S. Centers for Disease Control and Prevention has much connected supplier overdoses and deaths.

SOURCE: U.S. Food and Drug Administration, news release, May 23, 2023; Indivior, news release, May 23, 2023; Associated Press

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