Sage Announces Pivotal Phase 3 Trial Status for SAGE-217 in Major Depressive Disorder and Postpartum Depression based on FDA Breakthrough Therapy Meetin

- June 12th, 2018

Sage Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced its expedited development plan for SAGE-217 following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA). This development plan is intended to support a potential filing for approval of SAGE-217 in the … Continued

Sage Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced its expedited development plan for SAGE-217 following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA). This development plan is intended to support a potential filing for approval of SAGE-217 in the U.S. for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

As quoted in the press release:

The expedited development plan for SAGE-217 includes a single additional placebo-controlled Phase 3 pivotal trial in patients with MDD and the ongoing placebo-controlled trial in women with PPD, now designated a pivotal trial. Both clinical trials are designed to evaluate the novel concept of episodic dosing, or short course treatment, with SAGE-217 and its effect on the reduction of depressive symptoms compared to placebo. An open-label study will evaluate the potential of episodic treatment for recurrent or new major depressive episodes and provide additional safety data.

Sage plans to initiate the placebo-controlled Phase 3 trial in MDD during the second half of 2018. Further, Sage anticipates announcing top-line data from the placebo-controlled pivotal trial of SAGE-217 in PPD in the fourth quarter of 2018. This expedited pivotal program is supported by the results of a positive placebo-controlled trial in patients with MDD announced in December 2017.

Click here to read the full press release.

Are You Aware of the FDA's Plans for 2018?

Find out what's going on in our new report
 

Leave a Reply

Your email address will not be published. Required fields are marked *