Monthly update of U.S. Food and Drug Administration (FDA) approvals impacting the workers' compensation industry. myMatrixx's report includes new drug and indication approvals, discontinuation and withdrawals, new dosages or formulations of existing products and newly available generics in the last 12 months.
Monthly Drug News
The second opioid overdose reversal agent for over-the-counter (OTC) sale, RiVive (naloxone - Harm Reduction Therapeutics) nasal spray, 3 mg/0.1 mL, received approval from the U.S. Food and Drug Administration (FDA) on July 28, 2023. RiVive 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) 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 after the first spray. If needed, one additional spray can be given every two to three minutes until professional assistance arrives.
With its partner, Catalent, the manufacturer expects to deliver 200,000 doses of RiVive to first responders, state governments and other agencies free of charge. Although exact pricing for commercial sale has not been revealed, Harm Reduction Therapeutics, a nonprofit organization, states that its price will cover only the expense of making it; no profit will be realized from selling RiVive. Funding partners are being recruited to finance manufacturing and increase production.
Packaged in boxes containing two single-dose devices, its release to the U.S. market is planned for early in 2024. Narcan® (naloxone – Emergent BioSolutions) 4mg/0.1mL nasal spray was granted FDA approval for OTC sale in March 2023, but it is not yet available at retail or online. However, in the U.S., naloxone nasal spray, 4mg, can be dispensed at pharmacies without a prescription or it can be prescribed for a caregiver of an at-risk patient, depending on state regulations. Another intranasal product, Amphastar Pharmaceuticals’ Naloxone Nasal Spray, 4mg, is prescription-only, as is a higher strength formulation, Kloxxado® (naloxone nasal spray, 8mg). Neither presently has generic equivalents. Other dosage forms of naloxone remain prescription only, as well.
Impact to Workers’ Comp
Considering the potential for misuse of opioids, treatment of opioid overdose is of interest in those claims where an opioid has been prescribed. For any questions about the use of RiVive, naloxone, and potential relatedness to a claim, please consult with your myMatrixx pharmacist.