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 U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals’ Naloxone Nasal Spray, 4 mg, on March 7, 2023. It was approved as a new formulation, not a generic, because it has a patented delivery device. An opioid agonist, naloxone provides temporary reversal of opioid overdoses in emergency settings. One dose (one spray) of naloxone 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. In the U.S., naloxone nasal spray, 4 mg, can be dispensed without a prescription or it can be prescribed for a caregiver of an at-risk patient, depending on state regulations.
Naloxone nasal spray, 4 mg, is available as the branded drug, Narcan® and in generic forms. A higher strength formulation, Kloxxado® (naloxone nasal spray, 8 mg) presently has no generic equivalents. Amphastar’s product will be available in boxes containing two single-dose sprays. Its distribution, launch and pricing plans have not been announced.
Impact to Workers’ Comp
Considering the potential of misuse and overdose, opioid antagonists are of interest in those claims where an opioid is prescribed. For any questions about the use of naloxone, opioids, and potential relatedness to a claim, please consult with your myMatrixx pharmacist.