Note - January 202`: A further update from Asarina Pharma regarding the placebo effect and PMDD has been released and can be found here.
Sepranalone was a PMDD-specific treatment developed by Asarina Pharma. It was a treatment that came in injection form and inhibited the effects of the GABA steroid allopregnanolone on a GABA-A receptor in the brain. This was to prevent PMDD symptoms from emerging. Sepranolone is a highly specific treatment, only inhibiting the effect of allopregnanolone on the receptor.
Clinical trials were looking very promising, with studies demonstrating a positive safety and tolerability profile for Sepranolone, and whilst a substantial reduction in PMDD symptoms was achieved across the patient population, sadly a statistically significant difference compared to placebo was not observed for the study’s primary and secondary endpoints, due to the unexpectedly high placebo effect.
Whilst this treatment will not continue to be developed by Asarina Pharma for the treatment of PMDD, they will continue its development programs for Sepranolone in menstrual migraine and Tourette syndrome.
Read Asarina Pharma’s statement on the release of these findings here.
Watch the Asarina Pharma press release on the news of the Stage 11b clinical trials results (April 2020) here: