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news.Sosei Group has received approval from the UK Medicines and Healthcare products Regulatory Agency for the Phase III clinical trial program for fentanyl sublingual spray, an opioid analgesic for the treatment of cancer breakthrough pain.
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The clinical trial authorization (CTA) covers two multi-center pivotal Phase III efficacy studies followed by an open label safety study. Patient enrolment in the UK is expected to commence before the end of the year and will be the subject of a separate announcement. Applications have been made in other European countries and further patient recruitment will be initiated as soon as approval is received from the relevant local regulatory body.
This first CTA in a major European country will also trigger the receipt of a project milestone payment under the AD 923 license agreement signed with Mundipharma in June 2006.
Shinichi Tamura, president and CEO of Sosei, said: “Receipt of our first Phase III CTA represents an important milestone in the evolution of Sosei and the continuing progress of the AD 923 development program. We look forward to enlisting our first patients in the trial.”