Reprinted with the kind permission of Cort Johnson and HealthRising .
It’s not often that you see a 1,000 person drug trial for fibromyalgia or any other disease, but one recently begun in the U.S. and Canada. A Japanese drug company, Daiichi Sankyo , is making a huge bet on a new drug called mirogabalin for fibromyalgia and other diseases.
If mirogabalin sounds vaguely familiar it should. Daiichi Sankyo believes mirogabalin is a significant upgrade of pregabalin, e.g. Lyrica. Both drugs bind to calcium channels that have been implicated in the production of neuropathic pain.
Mirogabalin is believed to bind to a calcium channel subunit that has strictly analgesic, i.e. pain reducing, properties. Lyrica, on the other hand, also binds to another subunit that has central nervous system effects that may be responsible for its side effects. Mirogabalin, Daiichi Sankyo believes, will be more potent, have fewer side-effects and be longer-acting than Lyrica.
That would be a winning combination for the many fibromyalgia sufferers who either didn’t derive benefit from the Lyrica or not enough benefit to stay on it. Lyrica’s reputation for producing side-effects has become so pervasive that the company is working with researchers to try and determine what kinds of fibromyalgia patients it works for and which kinds it doesn’t.
Despite the side-effect issues, Lyrica has been a veritable cash cow for Pfizer. Sales reached a high of $624 million in the US in the last quarter of 2013. Pfizer, its manufacturer, was so enamored of it (and three other drugs) that for years it promoted Lyrica for uses it had not been approved for. (That little mistake left the company with a cool $2.3 billion dollar fine a couple of years ago.)
It is generic in Europe and is expected to go generic in the U.S. in 2018.
Will Head-to-Head Trial Topple Lyrica?
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A 2014 study examining mirogabalin’s effectiveness in diabetes patients with peripheral neuropathy suggested it may indeed be more effective. In fact, the short study suggested it may be 17 times more potent than Lyrica. Outside researchers have suggested that the study was marred by a short time-frame – just five weeks – that may not have allowed Lyrica to reach it’s optimum effectiveness. A recent meta-analysis of Lyrica studies, however, found that most of the gains from Lyrica come in the first three to four weeks.
Daiichi Sankyo is clearly confident it’s struck gold with this drug. It’s begun very large, very expensive phase three trials of mirogabalin in three disorders. Two Asian trials of 750 patients in 200 centers will assess its effectiveness in diabetic neuropathy and postherpetic neuralgia. A 1,000 person U.S./Canadian trial is assessing its effectiveness in fibromyalgia.
The trial makeup – putting mirogabalin head to head with Lyrica – the number one drug for fibromyalgia – indicates Daiichi wants to topple the frontrunner and install mirogabalin as the preferred drug for FM at the same time.
The 13-week trial will test mirogabalin’s effectiveness in reducing pain and fatigue and improving sleep, mood and quality of life. It began in Oct, 2014 and is expected to last until 2017. Ninety-four study locations are present in the U.S. and Canada. Contact Daiichi using this email – SM_DS5565_FM_Info@incresearch.com – if you’re interested in being in a trial.
If mirogabalin is successful it will be the third of a family of drugs, beginning with gabapentin (Neurontin) and continuing with Lyrica, that have made it to market.
The success of this family of drugs has prompted drug companies to find ways to improve them. After several failures, Pfizer, for instance, found that one key to the potency of this drug line is it’s ability to pass through the blood-brain barrier. Subsequently it found an analogue called 4-methylpregabalin that proved several times more potent in animals than Lyrica. Pfizer got so far behind in its search for the “next Lyrica,” though, it’s not clear if it will attempt to bring it to market. The only Pfizer funded Lyrica trial underway right now is in China.