Sepranolone 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.
July 2024 Update
As you may know, IAPMD has been on the watch for updates on Sepranolone (a PMDD specific treatment) since April 2020. Unfortunately, Asarina Pharma will not be continuing their work on Sepranolone as of July 18, 2024.
A press release stated that they had been actively searching for a partner company to further develop their key drug - Sepranolone - into the next phase of the clinical trial. However, after reaching out to 200 companies and having active discussions with 20 companies, their partnership efforts did not come to fruition. The interested companies did not offer to license or acquire rights to continue studying Sepranolone.
Based on their balance sheets for May 2024, Asarina Pharma's board concluded that the company is in dire financial difficulties. They have announced a decision to liquidate assets, which means that they are in the process of bringing the business to an end.
What does this mean?
Sadly, it looks like Sepranolone will never reach the market for any indication despite promising results in luteally-confined PMDD and Tourette's syndrome.
September 2021 Update
You may recall that the much-anticipated release of the topline findings on Sepranolone (a PMDD-specific treatment) back in April 2020 were met with disappointment from the PMDD community - while clinical trials initially looked very promising, 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. From this point, the development of Sepranolone as a treatment for PMDD was no longer continued by Asarina Pharma, but they continued its development programs for Sepranolone in menstrual migraine and Tourette syndrome.
In September 2021, The publication of Asarina Pharma’s phase IIb study, including a post hoc analysis by leading PMDD experts, demonstrated that Sepranolone in a 10 mg dose did have a significant treatment effect compared with placebo when examined in an extended 9-day analysis of symptom reduction.
Read the full paper HERE
So what does that mean?
While this update is good news in terms of knowing that Sepranolone does significantly improve the symptoms of PMDD - the ongoing development of Sepranolone for PMDD can only move forward with a collaboration between Asarina Pharma and a large pharmaceutical partner. A new study (clinical trial) would need to involve at least 6 months of treatment (clinical trials) and several hundred patients - an expensive procedure which is not possible for Asarina Pharma alone, so, currently the development of PMDD as a treatment for PMDD has been shelved for the time being. There is still hope that in the future this research will be picked up and continue, but at present, this will depend on future partnerships with a pharmaceutical company with the means to continue this vital research.
We will continue to update this page with any developments.
June 2021 Update - Topline results from its Phase IIa study of Sepranolone for the treatment of menstrual migraine showed a 25% reduction in menstrual migraine days was achieved across the patient population. However, a statistically significant difference compared to placebo was not obtained for the study’s primary and secondary endpoints and so this treatment will no longer continue to be developed at this time for menstrual migraines.
Read Asarina Pharma’s statement on the release of these findings here.
Asarina Pharma will continue its development program for Sepranolone as a treatment for Tourette syndrome.
January 2021: A further update from Asarina Pharma regarding the placebo effect and PMDD has been released and can be found here.
April 2020 Update - 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.
From this point, the development of Sepranolone as a treatment for PMDD was no longer continued by Asarina Pharma, but they continued 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:
On May 5th 2020 - we put patient questions to Karin Ekburg, Chief Operating Officer from Asarina Pharma. You can listen here:
