As discussed earlier, Sage Therapeutics’ (SAGE) portfolio includes products under development for the treatment of life-threatening central nervous system (or CNS) disorders through two different programs: GABA receptor systems and NMDA receptor systems.
The above chart shows the product portfolio for the GABA receptor program.
GABA receptor-based products
Gamma-aminobutyric acid (or GABA) is an inhibiting neurotransmitter in the CNS. The products in the GABAA Receptor program, their uses, and status of development are as follows:
- Brexanolone (or SAGE-547) is the lead product candidate from Sage Therapeutics and is under the registration phase for the treatment of postpartum depression. The US FDA has accepted the company’s new drug application and granted priority review to Brexanolone IV for the treatment of postpartum depression. The Prescription Drug User Fee Act (or PDUFA) target date is December 19. If approved, the drug will be the only approved medicine for the treatment of postpartum depression.
- SAGE-217 is a drug under phase three development for the treatment of postpartum depression and major depressive disorder. It’s under phase two development for the treatment of bipolar depression and insomnia. In June 2018, Sage Therapeutics and Shionogi & Co. announced a strategic collaboration for the development and commercialization of the drug SAGE-217 for major depressive disorder and other indications for Japan, South Korea, and Taiwan.
- SAGE-324 is a drug under development in phase one clinical trials for the treatment of Parkinson’s disease, essential tremor, and epileptiform disorders.