Postpartum Depression (PPD)
PPD is a mood disorder that affects about 15% of women within the first year of childbirth. Women with PPD experience feelings of extreme sadness, hopelessness, suicidal ideation, anxiety, and fatigue. These symptoms mirror those of a major depressive episode with the additional criteria that the onset of depression occurs within 4 weeks of childbirth. PPD can affect a mother’s ability to care for her child and may negatively affect a child’s cognitive development.
The most common medications prescribed to women who seek treatment for PPD are SSRI’s and SNRI’s, which have limited evidence of efficacy. There are currently no approved therapies to treat PPD.
PPD is thought to develop from rapid changes in the levels of endogenous neurosteroids during pregnancy. Plasma levels of allopregnanolone, which is a metabolite of progesterone and an endogenous gamma-aminobutyric acid (GABA) modulator, are known to increase throughout pregnancy and then precipitously drop after delivery. It is thought that these rapid hormonal changes are linked to triggering depression in women who are vulnerable to develop this condition.
Data were recently published demonstrating that a continuous infusion of allopregnanolone rapidly alleviates symptoms of depression in women with PPD. Ganaxolone, a synthetic analog of allopregnanolone, may provide benefit to these women.
We are preparing to initiate a Phase 2 double-blind, placebo-controlled, multi-center, dose-finding study to evaluate the safety, efficacy and pharmacokinetics of ganaxolone in women with PPD. We plan to evaluate dosing regimens utilizing our intravenous (IV) and oral dose forms of ganaxolone, which will inform dosing for future pivotal studies.