In the Magnolia Phase 2 clinical trial, 33 patients with PPD received either a 6-hour infusion of IV ganaxolone (20 mg/hr) followed by 28-days of oral ganaxolone (900 mg once daily) (n=16) or placebo (n=17). Hamilton Rating Scale for Depression (HAM-D17) measurements were conducted by a centralized rater and taken at various timepoints spanning from baseline to end of treatment, at 28 days. Ganaxolone was generally safe, well tolerated and provided clinically meaningful reductions in HAM-D17 scores at early time points of 6 hours and 24 hours after start of treatment. HAM-D17 scores at 28 days of treatment were not different from placebo. Consistent with previous ganaxolone studies, the most common reported adverse events were sedation, dizziness and somnolence. There were no serious adverse events reported, no discontinuations due to a treatment related adverse event and, consistent with prior studies, there were no reports of syncope or loss of consciousness.
In the Amaryllis Phase 2 clinical trial 25 patients with PPD received 675 mg of oral ganaxolone at dinner for 28 days (low dose) and 43 patients received 675 mg of oral ganaxolone at dinner and bedtime for two days, followed by a dinner time dose of 1125 mg once daily for the remainder of the 28-day treatment regimen (high dose). The high dose showed a HAMD-17 reduction at 24 hours of treatment that was approximately 2.0 points greater than the low dose, which was generally sustained over the treatment regimen, suggesting an efficacy trend with early activity onset. Oral ganaxolone was generally safe and well-tolerated with no serious adverse events reported and no discontinuations due to treatment related adverse events. We believe that data from the Amaryllis Study support continued use of the once daily 1125 mg oral dose in future clinical studies.