By Donna Gregory Burch.
The fibromyalgia community suffered yet another disappointment earlier this month when drugmaker Daiichi Sankyo announced mirogabalin, a potential new treatment, failed to meet its pain-reducing goals in clinical trials.
Last year, I reported that three potential new fibromyalgia drugs were heading to clinical trials. Two of those contenders – mirogabalin and TNX-102, a sublingual form of cyclobenzaprine, have now been shown to be ineffective for fibromyalgia. The third drug – an antiviral/anti-inflammatory combo named IMC-1 – will likely head to trial later this year.
Mirogabalin is a cousin of Lyrica, the first drug ever approved to treat fibromyalgia, but it was supposed to work better than Lyrica with fewer side effects. Unfortunately, mirogabalin didn’t live up to those claims.
“In the three, 13-week, double-blind, global, phase 3 ALDAY clinical trials evaluating mirogabalin for the treatment of pain associated with fibromyalgia, mirogabalin did not meet the primary efficacy endpoint to demonstrate a statistically significant reduction in the weekly average of worst daily pain score from baseline to week 13,” reads a Daiichi Sankyo press release.
The ALDAY trials involved more than 3,600 patients, ages 18 and older, from about 300 centers throughout North America, South America, Eastern Europe, Western Europe and the Asia Pacific region.
As blogger Cort Johnson summarized, “Daiichi Sankyo bet big, big money that its safer, more effective version of Lyrica called mirogabalin was going to be the next big thing in fibromyalgia. … They had good reason to be confident. Lyrica, mirogabalin’s predecessor, binds to a calcium channel subunit that has pain reducing and central nervous system effects. Those central nervous system effects are believed to cause its rather notorious side effects. Mirogabalin, on the other hand, binds to a calcium channel subunit believed to have strictly analgesic; i.e. pain reducing effects. In one fell swoop, Daiichi was going to produce a drug that was not only more effective but had fewer side effects and was longer-acting than Lyrica.”
But alas, fibromyalgia’s notoriously difficult-to-treat pain was too much for mirogabalin to handle. Despite its failure in fibromyalgia-related trials, Daiichi is not ready to concede defeat. When asked last week about the future of mirogabalin as a fibromyalgia treatment, spokesperson Alyssa Dargento said, “It is premature to comment on the regulatory submission plans for mirogabalin in the U.S.”
Asked if there will be future mirogabalin/fibromyalgia trials, she said, “At this time, the global clinical development program for mirogabalin consists of several phase 3 clinical trials, including NEUCOURSE [for post-herpetic neuralgia], REDUCER [for diabetic peripheral neuropathic pain] and ALDAY [for fibromyalgia pain]. The results from the global clinical development program will guide our path forward for mirogabalin.”
While mirogabalin didn’t meet pain-relieving goals for fibromyalgia, it did successfully reduce the weekly average daily pain score in patients with post-herpetic neuralgia in the NEUCOURSE trial.
With two of the three potential fibromyalgia drugs in limbo, the fibro community’s attention now shifts to IMC-1, a combination of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, being developed by Alabama general surgeon Dr. William “Skip” Pridgen and his company, Innovative Med Concepts. Pridgen and his research team believe the herpes simplex virus may be an underlying cause for fibromyalgia symptoms. He’s been treating fibro patients with his own version of IMC-1 for several years with promising results.
When asked last week for an update on IMC-1, Pridgen said, “[Innovative Med Concepts] has been spending the last six months finishing pill design/testing and completing needed toxicology studies, thus readying itself for the End of Phase 2 FDA Meeting. Additionally, we are in discussions with several pharmaceutical companies about a strategic partnership moving forward. We are still hoping to begin the first phase 3 trial this winter.”
Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.