Asarina Pharma, a drug development company focusing on the development of a novel therapy for severe premenstrual symptoms, has published the efficacy and safety data from the randomized, controlled trial involving a total of 120 women with PMDD, in Psychoneuroendocrinology.
Premenstrual Dysphoric Disorder (PMDD) is a condition with severe impact on the daily life of approximately 5 per cent of all women during their fertile years. The condition is caused by an altered sensitivity in the brain to an endogenous steroid produced following ovulation, resulting in monthly recurrent episodes of depression, anxiety and mood lability. Current treatment options include anti-depressants and oral contraceptives, which have little effect and are not well tolerated by patients.
Asarina’s lead product candidate, Sepranolone, is the first potential therapy to target the underlying cause of PMDD. Based on the efficacy data, that met the standard FDA primary endpoint for studies in PMDD and strong safety profile from the phase IIa study, Asarina is now preparing a Phase IIb clinical trial, to be conducted in the US, Germany, UK, Poland and Sweden with recruitment starting in the fall of 2017.
Asarina pharma's phase, clinical study, sepranolone in premenstrual, disorder meets primary endpoint
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