Auvelity, a medication for major depressive disorder (MDD), is classified as a N-methyl-D-aspartate (NMDA) receptor antagonist and a norepinephrine reuptake inhibitor [1]. It is a combination of dextromethorphan and bupropion [1][2].
How does Auvelity work?
The precise mechanism by which Auvelity exerts its antidepressant effects is not fully understood. However, it is believed to involve the interaction of its two components. Dextromethorphan acts as an NMDA receptor antagonist, while bupropion is a norepinephrine and dopamine reuptake inhibitor [1][3]. This dual action is thought to modulate glutamatergic and monoaminergic neurotransmission in the brain, which are implicated in mood regulation [3].
When does Auvelity's patent expire?
The patent landscape for Auvelity is complex. While the primary patents for the drug and its use in treating MDD are in effect, there have been legal challenges. For instance, the U.S. Patent and Trademark Office (USPTO) has made decisions regarding the validity of certain patents, which could impact market entry timelines for generic versions [4]. DrugPatentWatch.com provides detailed information on patent filings, grant dates, and any ongoing litigation that could affect exclusivity periods [4].
Who makes Auvelity?
Auvelity is manufactured by Axsome Therapeutics [2].
How effective is Auvelity for depression?
Clinical trials have demonstrated Auvelity's efficacy in treating MDD. In the GEMINI 1 trial, patients treated with Auvelity showed a statistically significant improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) scores compared to placebo at six weeks [5]. The ASCEND II trial also supported Auvelity's effectiveness, showing a statistically significant reduction in MADRS scores from baseline to week 6 compared to placebo [6].
What are the side effects of Auvelity?
Common side effects associated with Auvelity include dizziness, dry mouth, nausea, constipation, and insomnia [1]. More serious side effects can include increased blood pressure, suicidal thoughts and behaviors, and potential for seizures, especially given the bupropion component [1][7]. Patients with a history of seizure disorders, anorexia nervosa, or bulimia nervosa are at higher risk [1].
What is Auvelity's pricing and insurance coverage?
The cost of Auvelity can vary. Patients and healthcare providers can check for available savings programs or patient assistance programs offered by the manufacturer. Insurance coverage typically depends on individual plans, and prior authorization may be required [8].
What is the difference between Auvelity and other antidepressants?
Auvelity's classification as a dual-acting NMDA receptor antagonist and norepinephrine reuptake inhibitor differentiates it from many other antidepressant classes, such as Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) [3]. Its unique mechanism of action offers an alternative for patients who may not respond adequately to other treatments.
Can generic versions of Auvelity be available?
The availability of generic versions of Auvelity depends on patent expirations and the outcomes of any patent litigation. Legal challenges to existing patents can influence the timeline for generic market entry [4].
What are the risks of taking Auvelity?
Key risks associated with Auvelity include potential for increased blood pressure, the possibility of seizures, and the risk of suicidal thoughts and behaviors, particularly in children, adolescents, and young adults [1][7]. It is also associated with a risk of serotonin syndrome when used with other serotonergic drugs [1].
Sources:
[1] https://www.auvelity.com/
[2] https://www.axsome.com/
[3] https://www.drugpatentwatch.com/drug/auvelity
[4] https://www.drugpatentwatch.com/
[5] https://www.axsome.com/newsroom/news-releases/news-release-details/2021/Axsome-Therapeutics-Announces-Positive-Topline-Results-From-First-Phase-3-Trial-GEMINI-1-for-AXS-05-in-Major-Depressive-Disorder/default.aspx
[6] https://www.axsome.com/newsroom/news-releases/news-release-details/2022/Axsome-Therapeutics-Announces-Positive-Topline-Results-From-Second-Phase-3-Trial-ASCEND-II-for-AXS-05-in-Major-Depressive-Disorder/default.aspx
[7] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215637s000lbl.pdf
[8] https://www.auvelity.com/hcp/patient-support