“The FDA IND approval in menstrual migraine is an important validation of the strong safety profile of our compound and also has very positive implications for our upcoming larger clinical PMDD trials.” said Peter Nordkild, CEO of Asarina Pharma.
“All preclinical and clinical data on Sepranolone, over 100 documents in all, were submitted to the FDA for review and Sepranolone was cleared with an excellent safety profile. As a compound produced naturally in the body we expected that, but of course FDA confirmation is a crucial milestone.” said Märta Segerdahl, Chief Medical Officer of Asarina Pharma.
Asarina Pharma will soon start its phase IIa proof-of-concept study in menstrual migraine in Finland, Denmark and Sweden with 80-90 patients aged 18-45 years. The study is expected to be completed by the end of 2020.
About menstrual migraine and Sepranolone
Menstrual migraine (MM) is a predictably recurrent, highly specific and disabling form of migraine. Approximately 50 million women worldwide suffer from MM, which is often resistant to standard migraine treatments. MM is triggered by the naturally produced neurosteroid allopregnanolone. Sepranolone inhibits allopregnanolone and might thus prevent the development of MM. Sepranolone is preventive, endogenous and the first compound to target the specific mechanism that triggers MM.