Tokyo, Japan – 12 February 2008: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), a biopharmaceutical company, today announces that it has commenced Phase III studies for its fentanyl sublingual spray (AD 923), an opioid analgesic for the treatment of cancer breakthrough pain.
The trial is a multi-centre, randomised, double-blind, double-dummy, crossover study to evaluate the safety and efficacy of AD 923 against an active comparator (morphine sulphate immediate release (MSIR)) for the treatment of breakthrough pain in patients with malignancies. The primary endpoint is the well established summary of pain intensity difference (SPID) measure over the first 30 minutes from initial dosing.
Overall, the European Phase III programme will involve some 300 patients in two studies, involving an active comparator, across 10 European countries. These will then be followed by a single combined open label study to assess the long term effectiveness, safety and tolerability of AD 923.
In June 2006, Sosei entered into an agreement with Mundipharma International Corporation Limited for the development and commercialisation of AD 923 in Europe and other international markets, excluding North America and Japan. Sosei is currently evaluating its commercialisation options for the un-partnered territories.
Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that we are able to announce the start of Phase III studies. AD 923 has been optimised to meet the well recognised need for a safe and effective method of delivering fentanyl for the rapid relief of breakthrough pain in malignant and also non-malignant conditions”