Depression is a common mental illness characterized by high prevalence, high relapse rate, and high disease burden. While existing antidepressants are generally effective, unmet clinical needs remain regarding their speed of onset, remission rate, and patient adherence. Statistics show that the lifetime prevalence of depressive disorders among adults in China is as high as 6.8%, with 3.4% suffering from depression. Currently, the number of people suffering from depression is approaching 100 million, meaning one in every 14 people suffers from depression.
On May 15, 2026, according to the latest information on the website of the Center for Drug Evaluation (CDE) of China, the marketing application for dextromethorphan-bupropion extended-release tablets submitted by CSPC Ouyi Pharmaceutical Co., Ltd. under Category 3 chemical drug registration was accepted. According to publicly available information , the drug's indication is for the treatment of depression in adults .
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Publicly available information shows that dextromethorphan-bupropion extended-release tablets consist of two components: dextromethorphan and bupropion. They are innovative oral NMDA receptor antagonists with multiple mechanisms of action. Dextromethorphan is a non-competitive NMDA receptor antagonist and also a sigma-1 receptor agonist; bupropion inhibits the degradation of dextromethorphan, increasing its blood concentration and prolonging its half-life. These mechanisms distinguish it from traditional monoamine antidepressants, providing a new oral treatment option for adult patients with depression.
On August 24, 2022, Axsome Therapeutics announced that the U.S. FDA had approved Auvelity (dextromethorphan + bupropion) extended-release tablets for the treatment of adult patients with depression (MDD). According to the company's press release, Auvelity is the first oral therapy for depression with a novel mechanism of action in over 60 years. Its introduction is expected to provide patients with depression with a new, rapidly effective treatment option.
This drug exerts a rapid antidepressant effect through dual targets:

Dextromethorphan (45mg): As a non-competitive NMDA receptor antagonist and σ-1 receptor agonist, it regulates glutamatergic neurotransmission to achieve rapid mood improvement;

Bupropion (105mg): It acts as a CYP2D6 enzyme inhibitor, prolonging the half-life of dextromethorphan, and also as a norepinephrine-dopamine reuptake inhibitor.

Clinical data show that dextromethorphan-bupropion extended-release tablets can significantly shorten the onset time of antidepressant effects : symptom improvement can be observed as early as week 1 of treatment (P=0.007), and the difference is even more pronounced in week 2. After 6 weeks of treatment, patients' MADRS scores decreased by an average of nearly 16 points, and nearly 40% of patients (39.5%) achieved the clinical remission criteria, which is more than twice that of the placebo group (P<0.001).
As of now, neither the original nor generic versions of dextromethorphan/amphetamine extended-release tablets have been marketed in China. On April 30, 2026, Enhua Pharmaceutical submitted a marketing application for dextromethorphan/amphetamine extended-release tablets , which was accepted. This time, CSPC Pharmaceutical Group is the second company to submit a first-to-market application for this drug, marking the beginning of the competition for the first generic version.
Dr. Maurizio Fava, a psychiatrist at Massachusetts General Hospital, stated, “The approval of Auvelity represents a milestone in the treatment of depression. It features an innovative mechanism of action for oral NMDA antagonists, clinically proven rapid antidepressant effects, and a relatively good safety profile. Auvelity has been granted Breakthrough Therapy designation by the FDA, representing the first oral therapy for depression not based on monoamine neurotransmitters in over 60 years. With effects observed as early as one week after administration and sustained efficacy, Auvelity has the potential to significantly impact the treatment paradigm for depression.”
Major depressive disorder is a debilitating chronic illness characterized by depressed mood, inability to feel joy, guilt and worthlessness, lack of energy, and other emotional and physical symptoms, which can lead to suicide in severe cases. It is estimated that approximately 21 million American adults experience major depressive disorder each year. Nearly two-thirds of diagnosed and treated patients do not achieve an adequate response to available first-line treatments, highlighting the need for new therapies.
In summary, dextromethorphan/amphetamine extended-release tablets have a rapid onset of action in treating adult patients with MDD, significantly improving depressive symptoms within one week of treatment . After two weeks of treatment, the clinical cure rate was significantly higher than that of placebo, and this improvement persisted until the end of treatment. Finally, it is hoped that the first generic version of dextromethorphan/amphetamine extended-release tablets will be approved for marketing in China as soon as possible. This would not only fill a gap in the domestic market but also provide more treatment options for a wider range of patients with depression.

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