SOSEI BEGINS CLINICAL DEVELOPMENT OF SUBLINGUAL FENTANYL
Sosei announced that it has begun a Phase I comparative pharmacokinetic study of AD 923, its novel sublingual fentanyl spray for the treatment of cancer breakthrough pain, under an investigational new drug application.
The trial is a single-center, open-label, single-dose, crossover study to investigate the comparative pharmacokinetics of AD923 versus intravenous and oral transmucosal formulations of fentanyl in 24 healthy human volunteers.
"There is a major requirement for a simple and manageable method of providing immediate-release fentanyl for the rapid relief of breakthrough pain, which AD 923 has been optimized to deliver," Shinichi Tamura, president and CEO of Sosei, said.
AD 923 is a sublingual formulation of the opioid analgesic fentanyl that has been specifically designed to provide rapid onset of analgesia in a way that is easy to use by either the patient or caregiver. The device contains a lockout system that prevents inadvertent overdose.