Sosei initiates Phase III studies for cancer pain treatment

The trial is a multi-centre, randomized, double-blind, double-dummy, crossover study to evaluate the safety and efficacy of fentanyl sublingual spray (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 program 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.

Shinichi Tamura, president & CEO of Sosei, said: “AD 923 has been optimized to meet the well recognized need for a safe and effective method of delivering fentanyl for the rapid relief of breakthrough pain in malignant and also non-malignant conditions.”