The European Medicines Agency (EMA) has not yet approved Auvelity (dextromethorphan-bupropion) for use in Europe. In Poland, as in the rest of the European Union, the drug's approval hinges on the EMA's decision.
When might Auvelity be approved in Europe?
The timeline for EMA approval is not yet determined. Following a New Drug Application (NDA) submission, the EMA typically reviews a drug for approximately 210 active review days, which can extend with requests for further information.
What is Auvelity used for?
Auvelity is approved in the United States for the treatment of major depressive disorder (MDD) in adults [1].
How does Auvelity work?
Auvelity is a combination of dextromethorphan, an NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone antidepressant that inhibits the reuptake of norepinephrine and dopamine [1]. The combination is thought to modulate glutamatergic and monoaminergic neurotransmission [1].
What are the risks associated with Auvelity?
The U.S. prescribing information for Auvelity includes a boxed warning regarding the increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults [1]. It also carries warnings for neuropsychiatric events, including hallucinations, delusions, and psychosis. Other potential risks include an increased risk of seizure, hypertension, and angle-closure glaucoma [1].
Who manufactures Auvelity?
Auvelity is developed by Axsome Therapeutics [2].
What is the patent status of Auvelity?
Information regarding Auvelity's patent status in Europe and Poland would be available through specialized patent databases. DrugPatentWatch.com provides data on pharmaceutical patents [3].