It’s challenging to keep informed of new developments in medications and their uses. WMJ’s Pharmacotherapy Update aims to provide detailed information about current, cutting-edge topics in the pharmacy world.
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Cobenfy (xanomeline-trospium)
On September 26, 2024, the United States Food and Drug Administration (FDA) approved a new drug application, submitted by Bristol-Myers Squibb, for the combination product xanomeline and trospium chloride (Cobenfy) – the first antipsychotic drug approved to treat schizophrenia by targeting the cholinergic receptors rather than the dopamine/serotonin receptors. Cobenfy is the first drug to take a new approach in the treatment of schizophrenia and offers an alternative to previously approved antipsychotics.
Published online March 12, 2025.
Aduhelm (aducanumab-avwa) Controversy
Aducanumab (Aduhelm, Biogen) was approved under accelerated approval on June 7, 2021, by the US Food and Drug Administration (FDA) for treatment of Alzheimer’s disease. Much controversy has surrounded this initial ground-breaking approval and subsequent marketing rollout.
Published online August 20, 2024.
Inpefa (sotagliflozin)
On May 27, 2023, the US Food and Drug Administration (FDA) approved a new drug application, submitted by Lexicon Pharmaceuticals, Inc., for sotagliflozin (Inpefa), the first dual sodium-glucose cotransporter-1 and sodium-glucose cotransporter-2 inhibitor for the treatment of heart failure, including heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF).
Published online March 12, 2024.
Cannabidiol
Cannabidiol (CBD), a phytocannabinoid derived mainly from hemp, had captured the attention of researchers and consumer market through CBD legalization. There has been a surge in the number of clinical trials assessing the therapeutic effects of CBD and the accessibility of CBD to the public for a variety of health conditions. However, there is a lack of clinical evidence that supports the use of CBD. This update provides a high-level overview of different types of cannabidiol products and how they are regulated.
Published online August 28, 2023.
Auvelity (dextromethorphan/bupropion)
Auvelity was approved for the treatment of major depressive disorder (MDD) in adults on August 19, 2022, by the US Food and Drug Administration.
Published online January 30, 2023.
Paxlovid (nirmatrelvir/ritonavir)
Paxlovid was authorized for emergency use on December 22, 2021, by the US Food and Drug Administration (FDA) for treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVD-19, including hospitalization or death. Since it is not FDA-approved at this time, Paxlovid is considered an investigational drug.
Published online November 10, 2022.
Fluvoxamine and COVID-19
The past few years have witnessed several clinical studies that investigated the potential benefits of fluvoxamine maleate in treating COVID-19 patients. In December 2021, David R. Boulware, MD, MPH, a physician and researcher at the University of Minnesota, requested an emergency use authorization (EUA) for the use of fluvoxamine for early treatment of COVID-19 outpatients to prevent their clinical deterioration.
Published online June 6, 2022.
Aducanumab
Aducanumab was approved on June 7, 2021, by the US Food and Drug Administration (FDA) using the accelerated approval pathway. Under this approval category, a drug must be used for a serious condition that fills an unmet medical need. The outcomes in the study are based on surrogate endpoints thought to predict clinical benefit but are not themselves a measure of clinical benefit.
Published online April 2, 2022.
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