Pharmaprojects R&D Pipeline News Feed
Levonorgestrel completes Japanese Phase III trial
17 Jul 2008
Japanese biopharmaceutical company Sosei has announced that its emergency contraceptive pill, NorLevo (levonorgestrel) has completed a Phase III trial. NorLevo can be administered up to 72 hours following unprotected sexual intercourse.
In the Phase III trial in adult female subjects requiring emergency contraception, no adverse events were reported. In previous Japanese studies to assess safety and pharmacokinetics in female volunteers, it met all primary and secondary endpoints.
Mr Shinichi Tamura, CEO of Sosei enthused, "We believe that this product will meet one of the needs of Japanese women and that the trial will confirm that NorLevo is safe and effective in this population".
First launched in Europe in 1999, NorLevo is launched in over 50 countries worldwide. Sosei has exclusive rights to the product in Japan, as well as in Australia and New Zealand.