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Asarina Pharma: First patients begin Phase IIB trials of world’s first-ever therapy developed specifically to treat PMDD

Stockholm – April 24, 2018. The first patients arrived in clinics in Krakow, Poland and Berlin, Germany to take part in Phase IIB trials of the world’s first treatment for PMDD. CEO Peter Nordkild: “This is a milestone moment. Already having patients in the clinic, only ten days after the study opened, underlines the powerful need for a treatment that will alleviate the misery of the severest form of PMS.”

The phase IIB study is recruiting 225-250 patients from Sweden, UK, Germany and Poland, to trial Sepranolone in PMDD. It’s an endogenous compound, naturally occurring in the brain, which inhibits the effects of allopregnanolone, the steroid which triggers PMDD, the most acute, debilitating form of PMS. Symptoms, including mood swings, extreme irritability, anxiety, depression, and especially aggression can disrupt lives, relationships and careers.

The study opened April 11th, with applicants carrying out online questionnaires to ensure a diagnosis of PMDD. On April 20th the first patients entered clinics to begin in-patient screening. Their first task will be keeping diaries of their menstrual cycles, and the severity and frequency of their symptoms. The first administered therapies are expected to take place in June.

“These tests are critical,” says Peter Nordkild. “In Phase IIB patients administer the treatment themselves, at home, for up to two weeks every month, exactly as they will when the therapy reaches the market. This first diary-keeping stage is crucial and empowering. Many people suffer the debilitating symptoms of PMDD but don’t seek medical treatment because they think ‘this is just very severe PMS, and there is no treatment’. Well, we’re moving that treatment forward all the time. Sepranolone delivered some 80% symptom relief In Phase IIA clinical trials, and we’re confident it can treat PMDD—and help millions of women take back control of their lives.”

If you want more information on the study go here.