Japan's Sosei initiates Ph I NorLevo study

Tokyo, Japan-based Sosei Group says it has initiated a Phase I clinical trial for the emergency contraceptive pill SOH-075 (NorLevo). The company acquired the exclusive distribution rights to the product in Japan from Laboratoire HRA Pharma. It is currently approved and marketed in over 50 countries.

The randomized, double-blind, placebo-controlled trial is designed to evaluate the safety and pharmacokinetics of SOH-075 in healthy Japanese adult female volunteers. A total of 33 volunteers in three cohorts will be enrolled at a single study center.

NorLevo is an oral emergency contraceptive "morning after pill" which is used to prevent pregnancy after unprotected intercourse. It contains only levonorgestrel as an active ingredient. The dosing is started within 72 hours after unprotected . Since it inhibits pregnancy before the implantation of the egg, it is not a controversial pregnancy termination pill, says Sosei, but rather "a helpful opportunity for post-coital contraception. NorLevo has been successfully marketed in many countries and is both well-tolerated and effective as an oral emergency contraceptive for post-coital use."