Axsome Therapeutics, Inc discovers novel AUVELITYTM (dextromethorphan HBr -bupropion HCl) extended release tablets for the treatment of major depressive disorders in adults.
It is the novel oral NMDA receptor antagonist consisting of multimodal activity approved for the treatment of MDD in adults.
AUVELITY is the first approved treatment showing quick and significant improvements compared to placebo starting at one week for depressive disorders. AUVELITY, an extended extended-release oral tablet contains dextromethorphan HBr (45 mg) and bupropion HCl (105 mg).
Major depressive disorder (MDD) is a chronic, biologically-based disorder identified by low mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy, and other emotional and physical symptoms, and having a negative impact on social, occupational, educational, or other important functioning. In U.S, every year it is estimated that more than 21 million adults experienced MDD.
For major depressive disorder(MDD), AUVELITY is the first new oral mechanism of action approved in more than 60 years.
Some of the most common side effects of AUVELITY if taken more than twice as frequently as placebo include izziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis.
U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for auvelity™ for the treatment of major depressive disorders.