Millions of patients were thrilled when Lyrica became the first FDA-approved drug for fibromyalgia in 2007. But for many, Lyrica’s real-life performance didn’t live up to drugmaker Pfizer’s picture-perfect TV commercials.
Based on Pfizer’s research, only around 1 in 5 fibromyalgia patients experience at least a 50 percent or greater reduction in pain. And worst still, Lyrica is well known among those in the fibromyalgia community for its troubling side effects.
I know a few people whose lives have been changed by Lyrica, and I’m grateful for any treatment that helps – even if it only helps a small percentage of us. But at the end of the day, for most of us with fibromyalgia, Lyrica hasn’t lived up to the hype.
Japanese drugmaker Daiichi Sankyo is now testing what could be Lyrica 2.0.
Lyrica and Daiichi’s new drug, mirogabalin (aka DS-5565), both relieve pain by binding to the body’s calcium channels. For readers who love more technical explanations, Alyssa Dargento, Daiichi’s public relations director, explained how Lyrica and mirogabalin differ: “Like Lyrica, mirogabalin preferentially and selectively binds to the a2δ subunit of voltage gated calcium channel proteins, which may help to regulate how the brain processes pain signals. However, in vitro studies have shown that mirogabalin has a unique binding profile and long duration of action at voltage gated calcium channels.”
In simple terms, Daiichi believes mirogabalin works better and with fewer side effects than Lyrica, and it’s investing millions in clinical trials to prove it. In fact, part of Daiichi’s research effort will involve pitting Lyrica and mirogabalin head-to-head against one another in trials.
“The clinical efficacy of mirogabalin was studied in two phase II, multicenter, randomized, double blind, placebo and active comparator-controlled adaptive studies in patients with diabetic peripheral neuropathic pain (DPNP),” Dargento said. “These data provided proof-of-concept for mirogabalin as a potential treatment for DPNP and suggested that mirogabalin may have utility in other chronic pain conditions, including fibromyalgia.”
Daiichi’s global ALDAY research program includes three phase III studies, which will compare various doses of mirogabalin, Lyrica and placebo in fibromyalgia patients with the main goal of relieving pain. There also will be an open label safety study. (ClinicalTrials.gov includes information on these trials.)
These are huge studies involving some 4,000 fibromyalgia patients at around 800 clinical centers worldwide. Daiichi is still recruiting patients for at least one of its studies.
“The top line results for the ALDAY phase III clinical trials are anticipated in calendar year 2017,” Dargento said. “We plan to share the results from the clinical trial program in publications and at medical meetings in the future.”
(As a footnote to this section, I read last year that Pfizer is working on a time-released version of Lyrica. I reached out to Pfizer at least twice in an attempt to interview someone for this story, but no one responded to my requests.)