Home / Health / FDA Greenlights Vanda's Bysanti for Mental Health
FDA Greenlights Vanda's Bysanti for Mental Health
21 Feb
Summary
- Vanda Pharmaceuticals' Bysanti drug is now FDA-approved.
- The drug treats schizophrenia and acute bipolar I disorder.
- Launch in the U.S. is expected in the third quarter.
The U.S. Food and Drug Administration has granted approval for Vanda Pharmaceuticals' new drug, Bysanti, indicated for the treatment of schizophrenia and acute bipolar I disorder. This decision by the FDA is a notable development for Vanda Pharmaceuticals, expanding its portfolio of psychiatric medications.
Bysanti, chemically known as milsaperidone, operates within the class of atypical antipsychotics. These medications work by influencing dopamine and serotonin receptors in the brain, which are key in regulating mood and cognitive functions.
The company has announced plans to introduce Bysanti to the U.S. market in the third quarter of the current year. This drug is similar in composition and effect to Vanda's existing approved drug, Fanapt, also used for these conditions.
Vanda Pharmaceuticals is also exploring Bysanti's potential as an adjunctive therapy for major depressive disorder, with study results anticipated later this year. Other antipsychotic medications available include those from Bristol Myers Squibb and Johnson & Johnson.
