Auvelity: A Paradigm Shift in Major Depressive Disorder Treatment
Major Depressive Disorder (MDD) is a persistent, disabling condition that presents a significant health concern, with a high rate of morbidity worldwide. Introducing Auvelity™, the pioneering and exclusive oral NMDA receptor antagonist designed for MDD treatment.
How Does Auvelity Work?
Auvelity™ is a cutting-edge pharmaceutical formulation of dextromethorphan and bupropion that acts as an N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal action. This unique antagonist property offers a compelling solution for adults struggling with MDD.
Created by Axsome Therapeutics, a US-based biopharmaceutical firm, Auvelity (AXS-05) is a breakthrough extended-release oral tablet that contains a meticulously formulated mix of 45mg dextromethorphan HBr and 105mg bupropion HCl.
As the first of its kind, Auvelity™ is distinguished by its beige color, round, film-coated bilayer tablets embossed with ’45/105′, packed into 30-tablet bottles.
Recognitions and Approvals for Auvelity
Auvelity received the prestigious breakthrough therapy designation from the US Food and Drug Administration (FDA) for MDD treatment in March 2019.
By June 2020, the remarkable medication earned another breakthrough therapy designation, this time for Alzheimer’s disease (AD) agitation treatment. The FDA accepted the new drug application under priority review in April 2021, subsequently approving Auvelity extended-release tablets in August 2022.
Addressing the Impact of Major Depressive Disorder
MDD is a debilitating mood disorder, marked by persistent feelings of depression, worthlessness, low energy, and an inability to experience pleasure. With estimated numbers reaching up to 21 million adults suffering annually in the US alone, MDD is a major cause of disability worldwide.
Standard first-line therapies unfortunately often fail to deliver satisfactory results, underscoring the urgent need for innovative solutions like Auvelity.
Deciphering Auvelity’s Mechanism of Action
Auvelity’s dextromethorphan component is an uncompetitive NMDA receptor antagonist and a sigma-1 receptor agonist. These properties facilitate the modulation of glutamatergic neurotransmission.
Bupropion, the other key ingredient, enhances dextromethorphan bioavailability and operates as a norepinephrine and dopamine reuptake inhibitor.
Though the precise mechanism behind Auvelity’s MDD treatment remains a mystery, the drug is believed to interact with numerous brain receptors, influencing different neurochemicals.
Auvelity enjoys strong protection under 100 US and international patents, set to extend till at least 2037-2040.
Auvelity’s Efficacy Proven through Clinical Trials
In rigorous clinical trials involving more than 1,100 patients, Auvelity demonstrated promising results in treating MDD. Its efficacy was confirmed in two pivotal studies, GEMINI and ASCEND, with Auvelity significantly outperforming a placebo and bupropion hydrochloride sustained-release tablets.
Despite the effectiveness, users should be mindful of potential side effects, including dizziness, headaches, sleepiness, dry mouth, sexual function issues, and excessive perspiration.
Through these findings, Auvelity stands as a beacon of hope for patients with MDD, promising a new dawn in their therapeutic journey.