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Asarina Pharma recruits patients for Phase IIB trial of Sepranolone, world’s first treatment targeting PMDD, premenstrual dysphoric disorder

Patient enrolment is expected to be high for the Phase IIB clinical trial of Sepranolone, driven by strong medical need for a therapy that specifically targets PMDD, the severest form of PMS, in a market with few alternatives. Patients will be recruited in UK, Poland, Germany and Sweden.

Worldwide, 4-5% of all women of a fertile age currently suffer from PMDD. Symptoms can be devastating and disabling, disrupting relationships, family and working life. Yet no therapy specifically targeting the disease is available today, and the most commonly used treatment, SSRI anti-depressants, produce unwanted side effects. Asarina is committed to bringing Sepranolone to the market to address the high unmet medical need for these patients.

Asarina Pharma CEO Peter Nordkild: “Sepranolone is a natural, endogenous, first in class compound with a mode of action distinct from current therapies such as hormones and anti-depressants. Results generated so far are very promising and we’re excited to start our Phase IIB trial, to further develop this much-needed candidate drug into a powerful, effective new treatment.”

The phase IIB study is a randomized, placebo-controlled, double-blind clinical study enrolling 225-250 patients in Sweden, UK, Germany and Poland.

Peter Nordkild: “PMDD is still commonly un-diagnosed, so the early promising results of Sepranolone are encouraging as they clearly indicate that PMDD is a condition that can be treated. We understand why an increasing number of advocates and lobbying groups are turning round now and saying “let’s get real about PMDD” This is the beginning of the 21st century, so surely a safe, targeted, effective treatment can be developed to help the millions of women who suffer from this dreadful condition. Asarina is showing that such a treatment can and is being developed. We’re proud to keep moving this essential treatment forward, and to help more women remain in control of their life.”

In the US, PMDD has been a well-described diagnosis for 20 years. In Europe however, an EMA Guideline on PMDD exists, but the condition is still less recognized, with women sometimes misdiagnosed as having bipolar disorder or depression.