Daiichi Sankyo Company Ltd., the second largest pharmaceutical company in Japan, has just opened patient enrollment for a large-scale, international clinical research program, designed to determine the safety and efficacy profile of pipeline drug mirogabalin (DS-5565), a first-in-class selective alpha-2 delta ligand. The drug will be tested on peripheral neuropathic pain, postherpetic neuralgia, and pain secondary to fibromyalgia.
The newly-launched Phase III clinical research program includes 3 studies; two of which will be conducted all across Asia:
- REDUCER – An Asian, multicenter, RandomizEd, Double-blind, placebo-controlled 14-week stUdy of DS-5565 in patients with diabetiC pEripheral neuRopathic pain followed by a 52-week open-label extension study on the efficacy of mirogabalin in diabetic peripheral neuropathic pain (DPNP)
- NEUCOURSE – An AsiaN, phasE 3, mUltiCenter, randomized, dOUble-blind, placebo-contRolled 14-week study of DS-5565 in patientS with postherpetic neuralgia followed by a 52-week open-label Extension study on the efficacy of mirogabalin in postherpetic neuralgia (PHN)
- ALDAY – A Randomized, DoubLe-BlinD, Placebo- and Active-Controlled StudY of DS-5565 in Patients with Pain Associated with Fibromyalgia, which will evaluate mirogabalin for the treatment of pain associated with fibromyalgia in three identical studies.
“Pain associated with the neurologic conditions of diabetic peripheral neuropathic pain, postherpetic neuralgia and fibromyalgia can be debilitating,” said Lesley Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director of the Women’s Health Research Program, University of Cincinnati and lead investigator of the ALDAY program. “New treatment options are needed to help people living with these neurologic conditions relieve and manage their chronic pain and hopefully, improve their function and quality of life.”
“We are pleased that our global clinical development program evaluating the efficacy and safety of mirogabalin continues to move forward and has progressed into phase 3,” said Mahmoud Ghazzi, MD, PhD, Executive Vice President and Global Head of Development for Daiichi Sankyo. “Daiichi Sankyo is committed to identifying and studying new medicines that could help improve the management of chronic pain for people with diabetic peripheral neuropathy, postherpetic neuralgia and pain associated with fibromyalgia.”