Sage Therapeutics, a biopharmaceutical company, have announced a development plan for their Landscape Program evaluating zuranolone for the treatment of postpartum depression (PPD) and major depressive disorder (MDD).
This occurred after a Breakthrough Therapy guidance meeting with the US Food and Drug Administration (FDA). Sage Therapeutics has identified three potential pathways that could support a filing for zuranolone.
“Following FDA guidance, Sage has several potential pathways to bring zuranolone to patients, if we are successful, with two pathways that would represent unique indications that we believe we can progress quickly and efficiently, while in tandem we pursue our original approach to develop zuranolone for the episodic treatment of depression,” said Dr. Jeff Jonas, chief executive officer of Sage Therapeutics.
Sage Therapeutics will start three new clinical trials of its experimental antidepressant zuranolone. This is an attempt to move forward with the drug after a disappointing study setback that was announced three months ago.
“The development program for zuranolone is an example of Sage’s ability to think differently about depression, with the goal of providing treatment options that help people with depression get better, sooner. Sage is well-positioned for the path forward, and to continue advancing our multi-franchise strategy.”
The Landscape Program evaluates the potential of zuranolone as a rapid-acting, short-course oral treatment for PPD and MDD.
After discussions with the US FDA, Sage Therapeutics plans three new short-term clinical studies in 2020 in hopes of making three distinct indications. These indications include PPD, acute rapid response therapy in MDD when co-initiated with a new standard antidepressant, and episodic treatment of MDD.
The three clinical studies include the use as an oral therapy in women with PPD, use as an acute rapid response therapy (RRT) in patients with MDD when co-initiated with new standard antidepressant therapy and the use as an episodic therapy in patients with MDD.
Sage Therapeutics will balance cash, cash equivalents and others to support these operations into 2020.