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news.Sosei Group has completed a Japanese Phase III clinical trial for the emergency contraceptive pill SOH-075. Sosei acquired the exclusive distribution rights to the product in Japan from HRA Pharma.
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The clinical study was designed to evaluate the safety and prevented pregnancy rate of SOH-075 (NorLevo) in Japanese adult female subjects who require emergency contraception. No serious adverse events were reported during the study.
NorLevo is an oral emergency contraceptive ‘morning after pill’ which is used to prevent pregnancy after unprotected intercourse. NorLevo contains only levonorgestrel as an active ingredient. The dosing is started within 72 hours after unprotected sexual intercourse.
Shinichi Tamura, CEO of Sosei, said: “We are delighted to announce the completion of Phase III trial of SOH-075, which will be the first emergency contraceptive pill to be introduced into Japan.
“We believe that this product will meet one of the needs of Japanese women and that the trial will confirm that NorLevo is as safe and effective in this population as has already been demonstrated in other countries.”