The clinical study is designed to evaluate the safety and pharmacokinetics of NorLevo in healthy Japanese adult female volunteers.
NorLevo is an oral emergency contraceptive “morning after pill” which is used to prevent pregnancy after unprotected intercourse. Sosei commented that NorLevo has been successfully marketed in many countries and is both well-tolerated and effective as an oral emergency contraceptive for post-coital use.
“We are delighted to be able to commence our first trial of this product, which will be the first ECP to be introduced into Japan,” said Mr Shinichi Tamura, CEO of Sosei.
Sosei acquired the exclusive distribution rights to the product in Japan from Laboratoire HRA Pharma which is currently approved and marketed in over 50 countries.