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 Auvelity™ extended-release tablets on August 18, 2022. Indicated to treat adults who have major depressive disorder (MDD), it combines 45 mg of dextromethorphan, which is an N-methyl D-aspartate (NMDA) receptor inhibitor, with 105 mg of bupropion, which interferes with the activity of certain blood components. The result is higher blood levels of dextromethorphan and a longer duration of its effectiveness. In contrast to other current oral antidepressants, which may take several weeks to reach full effectiveness, Auvelity acts more quickly. In clinical studies comparing it to either placebo or bupropion, alone, it showed more positive effects at one week after the first dose and effectiveness lasted over the six-week long study periods.
Auvelity was approved under the FDA’s Breakthrough Therapy and Priority pathways. Its launch is planned for the fourth quarter of 2022, but the price is not yet determined.
Impact to Workers’ Comp
While depression isn’t the most common indication in workers’ compensation, any new antidepressant has the potential to impact a compensable claim. For any questions about the use of Auvelity, antidepressants, and potential relatedness to a claim, please consult with your myMatrixx pharmacist.