“Indivior’s Opvee Nasal Spray Approved by FDA for Emergency Treatment of Opioid Overdose”

The US FDA approved Indivior’s nalmefene nasal spray on May 22 for theEmergency treatment of patients with known or suspected opioid overdose. The drug is expected to be launched in the US under the brand name Opvee in the fourth quarter of 2023. OPVEE is approved through the 505(b)(2) pathway.

According to Opvee’s label, the nasal spray is indicated for use after exposure to natural opioids or synthetic opioids, such as fentanyl, over the age of 12.Patients with signs of respiratory and/or central nervous system depression, but onlylimited to emergency use，Not meant to replace regular emergency medical care.In addition, the label includes warnings and precautions for “repeated respiratory and central nervous system depression, severe opioid withdrawal, and risk of cardiovascular side effects.”While using this drug the most commonAdverse reactionsIncluding: nasal discomfort, headache, nausea, dizziness, hot flashes, vomiting, anxiety, fatigue, nasal congestion and throat irritation, nasal pain, decreased appetite, skin redness (erythema) and hyperhidrosis, etc.

Opvee is a nasal spray formulation of the opioid antagonist nalmefene, which works by blocking opioid receptors and can completely or partially reverse the effects of an opioid overdose. Opiant presented data from three studies confirming that intranasal nalmefene is both a safe and effective option:

1. Test one:Confirmatory pharmacokinetic studies. Data from 68 healthy subjects showed that intranasal administration of nalmefene resulted in faster drug absorption and higher plasma drug concentrations.
2. Test 2:Pharmacokinetic studies. Opvee was shown to be safe and well tolerated even with multiple doses.
3. Test three:Opvee is conducting a head-to-head comparison with competitor Emergent BioSolutions’ nasal spray Narcan (naloxone HCl).The study not only confirmed the non-inferiority of Opvee，It also showed that Opvee was superior to Narcan in “reversing remifentanil-induced respiratory depression within 5 minutes.”

Regarding the approval of Opvee, Jerome Adams, executive director of the Purdue University Health Equity Initiative, said that it will provide first responders with a fast, effective and long-lasting rescue drug option; FDA Commissioner Robert Califf also said that this approval is in line with the FDA’s “overdose prevention Framework to reduce harm from overdose by supporting the development of novel overdose products.

Further reading:Vaccine to stop opioid overdose effective in treating ‘hard-to-treat populations’
Further reading:“Detox Addiction” Preventing Opioid Overdoses and Deaths? “Vaccine” is the most potential prevention tool (worth reading)

Source: BioSpace, FDA, Company