There is no record of Auvelity receiving approval from the European Medicines Agency (EMA) as of the latest available information [1]. Auvelity is approved in the United States by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder in adults [2].
What is Auvelity?
Auvelity is an oral medication that combines dextromethorphan hydrobromide and bupropion hydrochloride [2]. It is used to treat adults with major depressive disorder [2].
Why hasn't Auvelity been approved in Europe yet?
The specific reasons for the lack of EMA approval for Auvelity are not publicly detailed. Pharmaceutical companies must submit extensive clinical trial data and manufacturing information to regulatory bodies like the EMA for review before approval can be granted. The process can involve multiple rounds of questions and additional data submissions [3].
How does Auvelity work?
Auvelity's mechanism of action involves its two active ingredients. Dextromethorphan is a low-affinity uncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and an agonist of the sigma-1 receptor. Bupropion is an aminoketone antidepressant that inhibits the reuptake of norepinephrine and dopamine. This combination is thought to modulate glutamatergic and monoaminergic systems, which play a role in mood regulation [2].
What clinical data supports Auvelity's efficacy?
The FDA approval of Auvelity was based on clinical trials, including two Phase 3 studies, which demonstrated a statistically significant reduction in depressive symptoms compared to placebo [2]. These studies, CAMEO-BD and ASCENT, involved a substantial number of adult patients diagnosed with major depressive disorder [4].
What are the side effects of Auvelity?
Common side effects reported for Auvelity include dizziness, nausea, headache, diarrhea, dry mouth, vomiting, constipation, tremor, abdominal pain, excessive sweating, and decreased appetite [2].
When might Auvelity seek EMA approval?
It is not possible to determine when or if Auvelity will seek or obtain EMA approval. The company developing Auvelity, Axsome Therapeutics, would need to initiate and complete the regulatory process for the European market [1, 3].
Are there other treatments for depression available in Europe?
Yes, numerous antidepressant medications are available in Europe and approved by the EMA for the treatment of major depressive disorder. These include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and others, each with their own profiles of efficacy and side effects [5].
How is Auvelity different from other antidepressants?
Auvelity's novel combination of dextromethorphan and bupropion differentiates it from many other available antidepressants, which often target monoamine systems alone. The dual mechanism involving NMDA receptor modulation and the inhibition of norepinephrine and dopamine reuptake offers a different therapeutic approach [2].
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**Sources:
[1] DrugPatentWatch.com
[2] Axsome Therapeutics. Auvelity Prescribing Information.
[3] European Medicines Agency. (n.d.). Submitting an application.
[4] Drug approval announcements and press releases from regulatory agencies and pharmaceutical companies.
[5] National Institute for Health and Care Excellence (NICE). (2022). Depression in adults: treatment and management.