A hit and a miss for Daiichi Sankyo's pain drug
- Topline data from several Phase 3 studies of Daiichi Sankyo's experimental pain drug mirogabalin turned up mixed results, showing a statistically significant benefit in post-herpetic neuralgia (PHN) but not in fibromyalgia pain.
- In the PHN study, dubbed NEUCOURSE, treatment with mirogabalin led to a reduction in weekly average daily pain score through week 14, meeting the trial's primary objective. NEUCOURSE tested mirogabalin only in Asian patients.
- Mirogabalin did not meet the primary endpoint in three Phase 3 trials testing the drug's effect on fibromyalgia pain, however. In each, mirogabalan did not show a statistically significant reduction in the weekly average of worst pain score from baseline through to week 13.
While the news signaled a success in PHN, Daiichi Sankyo wasn't clear about its plans for mirogabalin in fibromyalgia — only saying it will continue to study the drug and its use in pain syndromes.
Both post-herpetic neuralgia (a complication of shingles) and fibromyalgia pain are tough to treat. Physicians use a variety of drugs from topical patches through anticonvulsants, opioids and steroids.
While a number of companies are developing antivirals, few are focusing on the specific indication of post-herpetic neuralgia, which can be persistent and disabling.
A topical drug from Teva and Xenon Pharmaceuticals failed a Phase 2 trial last week, falling short of both the primary and secondary endpoints. The primary endpoint was a significant change in pain from baseline to week four, and the companies plan to further analyze the data before deciding on next steps.
Fibromyalgia pain is proving to be a challenging indication as well. Last September, a drug from Tonix Pharmaceuticals crashed out of Phase 3 trials, leading the company to shelve development in fibromyalgia and focusing on post-traumatic stress disorder instead.
- Daiichi Sankyo Press release
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