Health Canada has not yet approved Auvelity for use in Canada [1]. The drug, known chemically as dextromethorphan hydrobromide and bupropion hydrochloride, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults [2].
When might Auvelity be available in Canada?
The timeline for Health Canada's approval of Auvelity depends on the manufacturer's submission of a New Drug Submission (NDS) and the subsequent review process by the regulatory agency [3].
What is Auvelity used for?
Auvelity is indicated for the treatment of major depressive disorder (MDD) in adults [2]. It is a combination of dextromethorphan, an NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone antidepressant [2].
How does Auvelity work?
The exact mechanisms by which bupropion and dextromethorphan work in MDD are not fully understood. However, their individual and combined effects are believed to involve modulation of glutamatergic and monoaminergic neurotransmission [2]. Dextromethorphan binds to NMDA receptors and sigma-1 receptors, while bupropion inhibits the reuptake of norepinephrine and dopamine [2].
What are the side effects of Auvelity?
Common side effects reported in clinical trials for Auvelity include dizziness, nausea, headache, diarrhea, dry mouth, vomiting, constipation, and sexual dysfunction [2].
What are the risks associated with Auvelity?
Auvelity carries a boxed warning regarding the risk of suicidal thoughts and behaviors in children, adolescents, and young adults [2]. It also has warnings and precautions related to central nervous system (CNS) effects, such as hallucinations, delusions, and cognitive impairment, as well as potential for abuse and misuse of dextromethorphan [2].
Are there any drugs similar to Auvelity?
While Auvelity is a unique combination, other antidepressants target neurotransmitters like serotonin, norepinephrine, and dopamine. Specific comparisons would depend on the therapeutic class and mechanism of action of other available antidepressants [4].
Who manufactures Auvelity?
Auvelity is manufactured by Axsome Therapeutics, Inc. [2].
Are there any patents on Auvelity?
Information regarding specific patent filings and expiration dates for Auvelity can be found through specialized patent databases, such as DrugPatentWatch.com [5].
What is the regulatory status of Auvelity in other countries?
Auvelity is approved in the United States by the FDA [2]. Regulatory status in other countries, including Canada, varies [1, 2].
What are the clinical trial results for Auvelity?
Clinical trials have demonstrated Auvelity's efficacy in treating MDD. For example, in the GEMINI 1 trial, Auvelity showed a statistically significant reduction in depressive symptoms compared to placebo [2].
Patient concerns about Auvelity?
Patients may have questions about the drug's side effect profile, its novel mechanism of action, and how it compares to existing treatments for depression [4]. Concerns about potential abuse of dextromethorphan may also arise [2].
Sources:
1. https://www.canada.ca/en/health-canada.html
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216707s000,216708s000lbl.pdf
3. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/regulatory-information/drug-submission-process.html
4. https://www.nimh.nih.gov/health/topics/mental-health-medications
5. https://drugpatentwatch.com/