Depression Franchise

Sage is seeking to shift how certain mood disorders are understood and treated.

Sage is exploring new disease pathways for certain depressive disorders where there is a high unmet need for additional treatment options. We are working to understand the underlying mechanisms for numerous disorders of the brain to help us develop therapies that may address current treatment gaps for patients. We aim to change the possibilities for people with brain health disorders by making medicines that matter and creating a new understanding that depressive disorders are medical conditions that should be treated with urgency.

We focus our research and development efforts on modulation of GABA and NMDA receptors, two critical neurotransmitter systems that have responsibility for information flow within the intricate circuits of the brain and central nervous system. Both GABA and NMDA systems contribute significantly to regulating CNS function. However, dysfunction in these two systems is known to be at the core of numerous psychiatric disorders. Navigating these complex circuits is a challenge, but a welcome opportunity for the teams at Sage as we seek to provide new treatment options for patients.

We are using our unique development approach to evaluate our investigational drug candidates in postpartum depression (PPD) and major depressive disorder (MDD).

Postpartum Depression

According to the Centers for Disease Control and Prevention, mental health conditions are the leading cause of maternal mortality¹, with postpartum depression (PPD) among the most common complications during and after pregnancy.² During pregnancy, levels of certain hormones rise and then rapidly fall after giving birth. These hormone shifts may put some women at risk for developing this serious disorder. In the U.S., it is estimated approximately 1 in 8 women experience symptoms of PPD³ and approximately half of all PPD cases may go undiagnosed without appropriate screening.^4,5

Postpartum depression can have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, worry or feeling overly anxious, motor challenges, lack of concentration, loss of energy and poor self-esteem.

ZURZUVAE™ (zuranolone) CIV, in collaboration with Biogen, is the first and only oral, 14-day treatment now available for adults with postpartum depression.

ZULRESSO^® (brexanolone) CIV, an in-patient 60-hour infusion, was FDA approved in 2019 as the first treatment for patients 15 years and older with postpartum depression.

References

CDC: https://www.cdc.gov/media/releases/2022/p0919-pregnancy-related-deaths.html
ACOG Committee Opinion No. 757: Screening for Perinatal Depression. Obstetrics and gynecology vol. 132,5 (2018): e208-e212. doi:10.1097/AOG.0000000000002927
Bauman BL, Ko JY, Cox S, et al. Vital signs: postpartum depressive symptoms and provider discussions about perinatal depression - United States, 2018. MMWR Morb Mortal Wkly Rep. 2020;69(19):575-581
Georgiopoulos AM, et al. J Fam Pract. 2001;50(2):117-122
Evins GG, et al. Am J Obstet Gynecol. 2000;182(5):1080-1082