Daiichi Sankyo Company Limited announced enrollment of the first
patients in large-scale, multi-national clinical programmes evaluating
the safety and efficacy of investigational mirogabalin (DS-5565), the
first preferentially selective alpha-2 delta ligand.
The phase 3 clinical programme across Asia includes the REDUCER (An Asian, phase 3, multicenter, Randomised, 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 and the NEUCOURSE (An AsiaN, phasE 3, multicentre, randomised, double-blind, placebo-contRolled 14-week study of DS-5565 in patientS with postherpetic neuralgia followed by a 52-week open-label Extension) study which will evaluate investigational mirogabalin for the treatment of diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN), respectively. The phase 3 global ALDAY (A Randomised, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 in Patients with Pain Associated with Fibromyalgia) clinical programme is ongoing and 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,” says Lesley Arnold, MD, Professor of Psychiatry and Behavioural Neuroscience and Director of the Women’s Health Research Programme, University of Cincinnati and lead investigator of the ALDAY programme. “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.”
The phase 3 clinical programme across Asia includes the REDUCER (An Asian, phase 3, multicenter, Randomised, 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 and the NEUCOURSE (An AsiaN, phasE 3, multicentre, randomised, double-blind, placebo-contRolled 14-week study of DS-5565 in patientS with postherpetic neuralgia followed by a 52-week open-label Extension) study which will evaluate investigational mirogabalin for the treatment of diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN), respectively. The phase 3 global ALDAY (A Randomised, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 in Patients with Pain Associated with Fibromyalgia) clinical programme is ongoing and 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,” says Lesley Arnold, MD, Professor of Psychiatry and Behavioural Neuroscience and Director of the Women’s Health Research Programme, University of Cincinnati and lead investigator of the ALDAY programme. “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.”
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