FDA Approves New Naloxone Products

Posted on by myMatrixx
MyMatrixx Narcon Nasal Spray FDA Workers' Comp

Rezenopy (Naloxone Hydrochloride) Nasal Spray

A new prescription brand, Rezenopy (naloxone hydrochloride) nasal spray, was approved by the FDA on April 19, 2024. It contains a higher strength per dose (10mg/0.1mL) than the other naloxone products currently available in the U.S. If needed, one additional spray can be given in the opposite nostril if the first is unsuccessful, but no more than two doses should be given in any 24 hours. Rezenopy was developed by Summit Biosciences which recently was sold to Kindeva Drug Delivery. No details on cost, distribution or launch for Rezenopy have been announced.

Generic Naloxone Nasal Spray

On April 23, 2024, Amneal Pharmaceuticals received FDA approval for and launched naloxone nasal spray, 4mg/0.1mL, a generic to the OTC version of Narcan. Although the cost for Amneal’s product is not yet available, other OTC naloxone products retail for about $45 per box.

Clinical Information and Resources

Naloxone provides temporary reversal of opioid overdoses in emergency settings. By blocking opioid receptors, it displaces the opioid drug and decreases the negative effects of a drug overdose. One dose (one spray or injection) should be given as soon as an overdose is observed or suspected, based on the patient’s breathing difficulty and/or unconsciousness. Emergency medical help should be requested immediately and additional doses may be administered if the patient does not revive or relapses after the initial dose.

Naloxone nasal spray, 4mg/0.1mL, can be dispensed at pharmacies without a prescription, prescribed for a caregiver of an at-risk patient or obtained at emergency services facilities (usually police and fire stations), depending on state regulations. Another intranasal product, Kloxxado® (naloxone nasal spray, 8mg/0.1mL) is prescription-only. Two products, Narcan® (naloxone – Emergent BioSolutions) 4mg/0.1mL nasal spray and RiVive (naloxone - Harm Reduction Therapeutics) nasal spray, 3mg/0.1mL, are available over the counter (OTC). Injectable forms of naloxone are dispensed only with a prescription. All the products are packaged as two units per box.

MyMatrixx's Commitment to Getting Injured Workers Safely Back to Work and their Lives

As part of the Evernorth family, we at MyMatrixx are committed to ensuring injured workers receive the support they need to get back to fulfilling and productive activity. Our goal is to provide clinical value, innovative technology and actionable data analytics — all squarely focused on workers’ compensation patient advocacy.

Ask your MyMatrixx pharmacist if you have any questions regarding the newly FDA-approved Rezenopy or the new generic naloxone nasal spray available OTC. You can also reach MyMatrixx's clinical team at clinical@MyMatrixx.com

For additional naloxone facts and administer guidance, download MyMatrixx's Narcan one-page guide here.