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FDA grants Fast Track Designation to SAGE-217 for MDD

Sage Therapeutics recently received Fast Track Designation from the FDA for development of SAGE-217 as a potential treatment for major depressive disorder.

“The FDA Fast Track Designation is an important milestone in the development of SAGE-217, as it provides opportunities to potentially accelerate clinical development and future regulatory review of SAGE-217 for the treatment of [major depressive disorder],” Amy Schacterle, PhD, senior vice president of regulatory affairs and quality assurance at Sage, said in a press release. “Our discussions with regulatory agencies continue to focus on determining the most appropriate and efficient pathways for bringing new therapies to patients.”

SAGE-217 is an oral neuroactive steroid that is a positive modulator of synaptic and extra-synaptic GABA_A receptors. It is currently in phase 2 development for mood and movement disorders.

Four phase 2 studies are currently being conducted.

For more information:

Visit https://www.sagerx.com.