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Daiichi Sankyo’ pain drug mirogabalin meets primary end point in Neucourse phase 3 study

PBR Staff Writer Published 03 July 2017

Daiichi Sankyo's pain drug mirogabalin has showed mixed results in phase 3 global clinical development program.

The company has reported top-line results from Neucourse phase 3 clinical trial in patients with post-herpetic neuralgia and Alday phase 3 clinical trials in patients with fibromyalgia.

Mirogabalin is an oral therapy, which preferentially and selectively binds to the α2δ-1 (alpha-2 delta-1) subunit on calcium channels widely found in the nervous system in areas that mediate pain transmission and processing.

 Both studies are integral aspects of the firm’s global clinical development program for mirogabalin, which assessing its use in pain syndromes including post-herpetic neuralgia, fibromyalgia and diabetic peripheral neuropathic pain.

Neucourse is a single phase 3, double-blind, placebo-controlled and 14-week study assessing mirogabalin in 765 post-herpetic neuralgia Asian patients aged 20 years or older across 200 centers in Japan, Taiwan, Korea, Singapore, Malaysia and Thailand

In the trial, mirogabalin achieved the primary efficacy endpoint by showing a statistically significant reduction in the weekly average daily pain score (ADPS) from baseline to week 14.

The primary target of the Neucourse study was to assess the efficacy of mirogabalin in patients receiving 10mg or 15mg of mirogabalin twice-daily against placebo.

The three 13-week, double-blind, global and phase 3 Alday clinical trials, which assessing mirogabalin to treat pain associated with fibromyalgia, did not achieve the primary efficacy endpoint to show a statistically significant reduction in the weekly average of worst daily pain score from baseline to week 13.

Alday is a placebo and active-controlled, study of mirogabalin for fibromyalgia in three identical studies involving over 3,600 patients aged 18 years or older in around 300 centers across North America, South America, Eastern Europe, Western Europe and the Asia Pacific region.

 Daiichi Sankyo development global head and executive vice president Dr Marielle Cohard-Radice said:  “The Neucourse and Alday results provide us with important data and insights regarding the clinical profile of mirogabalin in specific pain populations.

“Daiichi Sankyo is committed to bringing innovative medicines to patients who need relief from pain, and we will continue to study mirogabalin and its potential use in pain syndromes as part of our ongoing global clinical development program.”


Image: Daiichi Sankyo has announced top-line results of its pain drug from phase 3 global clinical development program. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.