抑郁症不再是无药可医，Auvelity首个治疗成人重度抑郁症新药

Axsome is a biopharmaceutical company that develops and provides new treatments for central nervous system (CNS) diseases. It has recently brought good news in the development of depression drugs. The US FDA approved Auvelity (dextromethorphan 45 mg + bupropion 105 mg) compound extended-release tablets for the treatment of adults with major depressive disorder (MDD). Auvelity is the first and only fast-acting oral drug approved for the treatment of MDD.

(pixabay)

Auvelity depression oral drug trial process

Auvelity is based on research conducted in a comprehensive clinical program that included more than 1,100 patients with depression. The efficacy of Auvelity in the treatment of MDD was confirmed in the GEMINI placebo-controlled study. In the Phase III study of GEMENI, Auvelity was significantly better than placebo in improving depressive symptoms, with significant improvement on the Depression Rating Scale (MADRS) at 6 weeks. . In the ASCEND study, Auvelity was significantly better than placebo on the primary outcome. The primary outcome measure of the ASCEND study was by assessing change from baseline in total MADRS scores from weeks 1 to 6, with patients achieving significant improvement in depressive symptoms after just 1 week of treatment.

In terms of safety, in clinical studies controlled by placebo, the most common (incidence ≥5%) adverse reactions of Auvelity were dizziness, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction and hyperhidrosis.

About Auvelity

Auvelity is a novel oral NMDA receptor antagonist with multiple mechanisms of action approved for the treatment of major depressive disorder in adults. It contains dextromethorphan HBr (45 mg) and bupropion hydrochloride (105 mg). Dextromethorphan is a noncompetitive NMDA receptor antagonist and sigma-1 receptor agonist. These effects are thought to modulate glutamatergic neurotransmission. The bupropion ingredient in Auvelity is an aminoketone and CYP2D6 inhibitor that is used to increase and prolong the blood levels of dextromethorphan. However, Auvelity has received breakthrough therapy designation from the FDA for the treatment of major depressive disorder (MDD) in adults. It is also the first oral treatment for depression that is not based on monoamine neurotransmitters in 60 years, which is commendable.

About major depressive disorder (MDD)

While mild depression affects life by causing frustration and loss of interest, major depressive disorder (MDD) is a debilitating, chronic, biologically based disorder characterized by low mood, an inability to feel pleasure, feelings of guilt and worthlessness, low energy, and other emotional and physical symptoms that impair social, occupational, educational, or other important functioning. In severe cases, MDD can lead to suicide. Therefore, if you find depression, you should go to the hospital in time or take medication to control it to avoid unnecessary harm.

As the first rapid-acting antidepressant drug, Auvelity also contributes to the potential fundamental progress of neuropsychiatry. In the future, we expect that psychiatry can achieve clinical cure and treat more patients with depression.

References

axsome therapeutics announces fda approval of Auvelity™, the first and only oral nmda receptor antagonist for the treatment of major depressive disorder in adults

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.