Clinical Trials
In addition to facilitating PFS research, the PFS Foundation monitors FDA trials for potentially promising products in clinical development.
Sage Therapeutics has allopregnanolone and allopregnanolone analogue products that are currently in trials for various indications, including major depressive disorder and insomnia. Sage announced an expedited development plan for SAGE-217 in June 2018, following a Breakthrough Therapy meeting with the FDA. The plan is intended to support a potential filing for approval of SAGE-217 in the US for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). “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,” said Sage CEO Jeff Jonas.
- (May 2, 2022) Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application to US Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder
- (Dec. 5, 2019) Sage Therapeutics Reports Topline Results from Pivotal Phase 3 MOUNTAIN Study of SAGE-217 in Major Depressive Disorder
- (Sept. 5, 2019) The New England Journal of Medicine: Trial of SAGE-217 in Patients with Major Depressive Disorder
- (April 11, 2019) Neurologic disease research at UC Davis contributes to first treatment specifically approved for postpartum depression
- (March 19, 2019) Sage Therapeutics Announces FDA Approval of ZULRESSO (brexanolone) Injection, the First and Only Treatment Specifically Indicated for Postpartum Depression
- (Feb. 19, 2019) Sage Therapeutics Announces Fourth Quarter and Full Year 2018 Financial Results and Highlights Pipeline and Business Progress
- (Jan. 7, 2019) Sage Therapeutics Announces SAGE-217 Meets Primary and Secondary Endpoints in Phase 3 Clinical Trial in Postpartum Depression
- (Nov. 2, 2018) Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of ZULRESSO (brexanolone) Injection for Treatment of Postpartum Depression
- (June 12, 2018) Sage Announces Pivotal Phase 3 Trial Status for SAGE-217 in Major Depressive Disorder and Postpartum Depression based on FDA Breakthrough Therapy Meeting
- (Jan. 31, 2018) Sage Therapeutics Announces Positive Results from Placebo-Controlled Trial in a Model of Insomnia Demonstrating Activity on Sleep Parameters and Supporting Development of SAGE-217 as Potential Treatment for Sleep Disorders
- (Dec. 7, 2017) Sage Therapeutics Reports Positive Top-line Results from Phase 2 Placebo-Controlled Trial of SAGE-217 in Major Depressive Disorder
Research Goals
Determining the underlying biologic mechanisms of PFS, and in turn developing effective therapies for finasteride patients afflicted with the condition, requires ongoing clinical, basic-science and statistical research. Current research is focused on determining underlying biologic mechanisms for PFS at a molecular level, as will future initiatives. Specifically:
- Genetic risk factors for PFS
- Androgen receptor expression in PFS patients
- Hormonal profiles of PFS patients
- Full genome gene expression profiles and pathway analysis in PFS patients
- Proteins encoded by androgen responsive genes (ARGs)
- Neurosteroid levels in PFS patients
- Epigenetic chromatin alterations in PFS patients