See the DrugPatentWatch profile for Auvelity
Auvelity received U.S. Food and Drug Administration (FDA) approval on October 20, 2021 [1].
When was Auvelity first approved by the FDA?
The FDA approved Auvelity on October 20, 2021 [1].
What is Auvelity used to treat?
Auvelity is indicated for the treatment of major depressive disorder (MDD) in adults [1].
What are the active ingredients in Auvelity?
Auvelity is a combination product containing dextromethorphan and bupropion [1]. Dextromethorphan is an NMDA receptor antagonist, and bupropion is an antidepressant and smoking cessation aid that also inhibits the reuptake of norepinephrine and dopamine [1].
How does Auvelity work?
The pharmacological action of Auvelity is thought to be related to the combined effects of its active ingredients. Dextromethorphan acts as an antagonist at the N-methyl-D-aspartate (NMDA) receptor, while bupropion inhibits the reuptake of norepinephrine and dopamine [1].
What is the FDA approval history for Auvelity?
The FDA approved Auvelity on October 20, 2021 [1].
What is the patent expiration date for Auvelity?
Information regarding the specific patent expiration dates for Auvelity can be found on DrugPatentWatch.com [2].
Who manufactures Auvelity?
Auvelity is manufactured by Axsome Therapeutics [1].
What clinical trials led to Auvelity's approval?
The FDA approval of Auvelity was based on data from several clinical studies, including the GEMINI 1 and GEMINI 2 trials, which evaluated the efficacy and safety of the drug in adults with MDD [1].
What are the common side effects of Auvelity?
Common side effects reported in clinical trials for Auvelity include dizziness, headache, diarrhea, insomnia, and nausea [1].
Are there any warnings or precautions associated with Auvelity?
Auvelity carries warnings regarding potential risks such as suicidal thoughts and behaviors, as well as hypersensitivity reactions [1].
What are the alternatives to Auvelity for treating major depressive disorder?
Other treatments for major depressive disorder include various antidepressant medications such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants (TCAs), as well as psychotherapy [3].
What is the cost of Auvelity?
Pricing information for Auvelity is available through pharmaceutical databases and insurance providers.
Where can I find more information on Auvelity's patents and exclusivity?
DrugPatentWatch.com provides comprehensive data on pharmaceutical patents and market exclusivity for drugs like Auvelity [2].
What is the difference between Auvelity and other antidepressants?
Auvelity's unique mechanism of action, combining dextromethorphan and bupropion, differentiates it from many other antidepressants that primarily target serotonin or norepinephrine systems [1].