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 Opvee™ (nalmefene - Indivior) Nasal Spray as a new dosage form on May 22, 2023. It is a reversal agent indicated for patients as young as 12 years old who have signs of an opioid overdose, such as labored breathing and lost consciousness. Available in single-dose devices, directions are to administer one spray as soon as an overdose is observed or suspected, followed immediately by contacting emergency medical assistance. Additional doses may be given every two to five minutes if the patient does not respond or relapses before first responders arrive.

For 2022, the Centers for Disease Control and Prevention (CDC) reported about 80,000 Americans died due to opioid overdoses. Between six to eight times as many nonfatal overdoses, which put individuals at higher risk for subsequent overdoses and worsened overall health, are estimated to occur in the U.S. each year. Typically, nalmefene starts acting faster and stays active longer than a similar opioid antidote, naloxone. Additionally, it is more effective than naloxone for treating overdoses of synthetic opioids, including fentanyl. In a clinical study, the effects of Opvee began as soon as two and one-half minutes after administration and some patients recovered completely in as little as five minutes.

Some common side effects were anxiety, dizziness, excessive sweating, flushing, headache, nausea and nose or throat irritation. Its launch is planned for the fourth quarter of 2023. An injectable form of nalmefene that is available in the United States can be administered intravenously (IV), intramuscularly (IM) or subcutaneously (SC). Primarily, it is used by emergency services personnel. Several nasal and injectable naloxone products, including one that was FDA approved for over-the-counter (OTC) sales in March 2023, are marketed in the U.S., as well.

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 nalmefene, opioids, and potential relatedness to a claim, please consult with your myMatrixx pharmacist.