Product Details
SOH-075 is an emergency contraceptive pill used after unprotected sex, containing only levonorgestrel as an active ingredient. It inhibits pregnancy before the implantation of the egg in the uterus by several mechanisms involving changes to the uterine lining. It is not a controversial pregnancy termination pill, but a helpful opportunity for post-coital contraception. The first dose is taken within 72 hours after unprotected sex and the second 12 to 24 hours later.
In July 2008, a Phase III trial designed to evaluate the safety and prevented pregnancy rate of SOH-075 in Japanese adult female subjects who require emergency contraception was completed. Data showed that in 62 out of 63 subjects pregnancy was successfully prevented and no serious adverse events were reported.
In July 2008, a Phase III trial designed to evaluate the safety and prevented pregnancy rate of SOH-075 in Japanese adult female subjects who require emergency contraception was completed. Data showed that in 62 out of 63 subjects pregnancy was successfully prevented and no serious adverse events were reported.
Also, Sosei filed NDA application in September 2009 and signed definite distribution agreement with ASKA Pharmaceuticals for commercialisation of SOH-075.
Market Overview
This product was developed by Laboratoires HRA Pharma as Norlevo® and the exclusive distribution rights for Japan, Australia and New Zealand were licensed to Sosei in April 2001. It is already approved and marketed in more than 50 major EU/Asian countries. In December 2005, Sosei licensed the marketing right in Australia to Sandoz Pty Ltd. which now markets Norlevo in Australia.
