SPOTLIGHT -
Agents in late-stage development for the treatment of depression and generalized anxiety disorder
FDA Accepts NDA for Zuranolone for Depression
Zuranolone is a rapid-acting neuroactive steroid that can take effect in 14 days to treat patients with major depressive disorder and postpartum depression. The FDA has assigned a PDUFA action date of Aug. 5, 2023.
FDA Approves Vraylar for Major Depressive Disorder
This is the fourth indication for Vraylar, a dopamine and serotonin partial agonist that can now be used as an adjunctive therapy in patients with major depressive disorder.
EmpiRx Health Lowers Drug Spend in Mental Health
EmpiRx Health CEO Karthik Ganesh discusses how the PBM was able to decrease mental health drug spending at a time when utilization is increasing.
FDA Accepts NDA for Longer-Acting Aripiprazole
Aripiprazole, currently available as a once-monthly injection under the brand name Abilify Maintena, is being reviewed as a two-month therapy. The FDA target date for completion of the review is April 27, 2023.
FDA Approves Rapid-Acting Auvelity for Major Depression
Axsome anticipates Auvelity to be commercially available in the fourth quarter of 2022.
Tris Pharma Launches Dyanavel XR Tablets for ADHD
A clinical trial showed Dyanavel XR tablets were bioequivalent to the extended-release oral suspension formulation of Dyanavel.