Japanese pharmaceutical Daiichi Sankyo recently released top-line results of its Phase 3 trials investigating the safety and efficacy of mirogabalin in the treatment of pain for patients with fibromyalgia. Results of the trials, which were called ALDAY, showed that mirogabalin did not significantly decrease daily pain scores of participating patients.
Mirogabalin is an investigational drug that selectively blocks a subunit of calcium channels found in the nervous system and that participate in pain transmission and processing.
The three ALDAY trials (NCT02187159, NCT02187471, NCT02146430) were multicenter, randomized, double-blind, placebo-controlled, 13-week studies that investigated the safety and efficacy of mirogabalin (15 mg once a day or 15 mg twice a day) as a treatment for pain in more than 3,600 patients ages 18 or older with fibromyalgia.
The studies’ primary endpoint was a change in patients’ weekly average of worst daily pain scores. This average was calculated based on the daily pain scores reported by patients that best described their worst pain in the previous 24 hours.
Final results of the ALDAY trials in fibromyalgia patients will be presented at upcoming scientific meetings.
Daiichi Sankyo has an ongoing study to analyze the effects of mirogabalin in fibromyalgia patients with chronic kidney disease (NCT02496884).
Mirogabalin also was evaluated in the NEUCOURSE trial (NCT02318719) for the treatment of pain in patients with post-herpetic neuralgia, a condition that causes painful rashes. The NEUCOURSE trial was a Phase 3, double-blind, placebo-controlled, 14-week study assessing the therapeutic effect of mirogabalin in Asian patients.
Unlike the fibromyalgia trials, mirogabalin successfully met this study’s primary efficacy endpoint by significantly reducing the weekly average of daily pain scores in patients with post-herpetic neuralgia.
“The NEUCOURSE and ALDAY results provide us with important data and insights regarding the clinical profile of mirogabalin in specific pain populations,” Marielle Cohard-Radice, MD, Daiichi Sankyo’s executive vice president, said in a news release.
“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,” Cohard-Radice said.