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Enrollment launches for phase 3 studies of mirogabalin to treat diabetic peripheral neuropathy
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Daiichi Sankyo announced enrollment for two multinational phase 3 clinical trials to study an investigational drug to treat patients with diabetic peripheral neuropathic pain and pain associated with postherpetic neuralgia, according to a news release.
Mirogabalin (DS-5565), the first preferentially selective alpha-2 delta ligand, will be evaluated for safety and efficacy as a therapy for diabetic peripheral neuropathic pain in the REDUCER study and postherpetic neuralgia in the NEUCOURSE study.
The multicenter, randomized double-blind placebo-controlled trials both have a 14-week duration and 52-week open-label extension. An ongoing phase 3 ALDAY program is evaluating mirogabalin to treat pain associated with fibromyalgia.
“Pain associated with the neurologic conditions of diabetic peripheral neuropathic pain, postherpetic neuralgia and fibromyalgia can be debilitating,” Lesley Arnold, MD, of the University of Cincinnati, investigator on the ALDAY program, said in the release. “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.”
Mirogabalin is preferentially selective with a unique protein binding profile that could assist in brain regulation of pain signals and has a long duration of action.
The REDUCER trial is being conducted at approximately 200 centers in Japan, Taiwan and Korea, and the NEUCORSE at approximately 200 throughout Japan, Taiwan, Korea, Singapore, Malaysia and Thailand; both expect to recruit 750 patients.
The investigators will compare changes in average daily pain score from baseline to week 14 at daily doses of 15 mg, 20 mg or 30 mg of mirogabalin vs. placebo, according to the release.