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
An opioid overdose reversal agent, nalmefene injection, is being reintroduced to the U.S. after being off the market since 2008. The FDA approved an application from Purdue Pharma on Feb. 8, 2022, for two mL single-dose vials that contain two mg of the solution. It is indicated to block, at least partly, the adverse effects such as respiratory depression of opioid drugs and their overdoses.
Nalmefene, which has a longer lasting effect than another opioid antidote, naloxone, can be injected intravenously (IV), intramuscularly (IM) or subcutaneously (SC). If no response is seen in about five minutes, a second dose can be given. Additional doses probably will not help if the first two do not prompt a response from the patient.
Impact to Workers’ Comp
Purdue plans to supply nalmefene to emergency treatment facilities beginning mid-2022. For any questions about the use of nalmefene, naloxone, or opioids and potential relatedness to a claim, please consult with your myMatrixx pharmacist.