FDA Provides Expedited Path Forward For Sage’s Depression Treatment SAGE-217
By Alex Keown
Following a meeting with the U.S. Food and Drug Administration (FDA) SAGE Therapeutics is seeing the goal line for potential expedited approval of its major depressive disorder (MDD) and postpartum depression (PPD) treatment, SAGE-217 (brexanolone).
The FDA has requested an additional short-term Phase III trial for MDD patients. The trial will evaluate the novel concept of episodic dosing, or short course treatment as opposed to current long-term treatments. The additional Phase III trial will evaluate two weeks of dosing at 20 mg and 30 mg in 450 MDD patients. There will be an additional four weeks follow-up, Sage said. The FDA granted Breakthrough Therapy Designation to SAGE-217 for MDD in February.
Additionally, the FDA has designated the company’s ongoing placebo-controlled PPD trial 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. This development plan is intended to support a potential filing for approval of SAGE-217 in the U.S. for the treatment of MDD and PPD, Sage announced this morning.
If all goes well, Sage could file a New Drug Application for SAGE-217 by the end of the year.
Sage will also collect long-term data regarding patient safety and potential treatment of recurrent or new major depressive episodes. The company will follow 300 patients for six months and 100 patients for a full year after initial treatment.
Sage said it will initiate the new Phase III trial in MDD during the second half of the year. Topline date from the pivotal PPD trial is expected in the fourth quarter of 2018. So far, brexanalone has proven to be an effective treatment during clinical trials. Late last year brexanolone, an allosteric modulator of both synaptic and extrasynaptic GABAA receptors, hit the mark in both trials in two Phase III clinical trials. If brexanalone is approved, it would be the first FDA short-course drug approved by the U.S. Food and Drug Administration for severe PPD.
Jeff Jonas, chief executive officer of Sage, said the FDA feedback is exciting as it provides a “groundbreaking path forward” for the development of SAGE-217 for the treatment of depression.
“In this development program, we are exploring the potential for patients with MDD to feel well within days, with just a two-week course of treatment similar to how antibiotics are used today – instead of enduring long-term chronic treatment. We believe a medicine with rapid onset and robust response could be truly paradigm shifting. SAGE-217, if successfully developed and approved, may rewrite the textbook on how the tens of millions of people suffering from MDD are treated, ultimately turning depression into a disorder, not an identity,” Jonas said in a statement.
The news announced this morning has caught the ears of investors. Sage’s stock is up more than 3 percent in premarket trading to $151.50. The stock closed at $146.93 on Monday.