Biotech Company, Sage Therapeutics’ treatment brexanolone has passed the bar of efficacy in its two-phase 3 trials for woman with postpartum depression. The trials connected the intravenous formulation of allopregnanolone to strong enhancements on a depression scale, setting the company up to file for approval in 2018 and surging the stock to 44% gains.
There were 122 participants who suffered from PPD in one of the phase 3 trials and 104 women with moderate levels of the condition, respectively. Patients in both studies were administered a combination with either brexanolone or the placebo.
In both trials, they reported that brexanolone delivered versus the main endpoint of change in Hamilton Rating Scale for Depression. This is a huge confidence boost for the company, which is still battling back from the failed trials of brexanolone in super-refractory status epilepicus and advances hopes that a patient population that’s suffering with unmet medical need will be able to get the treatment they deserve soon.
“PPD is commonly viewed as a disorder solely experienced by the mother, but it also seriously impacts the child and family members, both immediate and extended,” Samantha Meltzer-Brody, M.D., head investigator reported in a statement. “These data meaningfully advance our understanding of PPD and may prompt medical professionals to evaluate how PPD is perceived, identified and treated within their practices in the future.”
The company plans on filing an NDA with the FDA in 2018.
Sage reported the effect of brexanolone seen following 60 hours was sustained through the 30-day follow-up, indicating the end of statistical significance is connected to improved results in the placebo arm. Furthermore, concerns about durability could become a topic to discuss as Sage begins dealing with the regulatory and re-payment obstacles that are in the way of it and sales of brexanolone.