Mirogabalin: Another Potential Fibromyalgia Drug has Disappointing Result

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When Dalichi Sankyo came up with a new drug called Mirogabalin they were certain they had discovered a goldmine. This new version of Pfizer’s medication Lyrica would end the suffering for millions of Fibromyalgia patients and it would be even more effective. While Lyrica binds to the calcium channel sub unit of the central nervous system to reduce pain precisely why the side effects are so notorious. A similar medication frequently used is Gabapentin (Neurontin), also with side effects that make it a huge risk. Mirogabalin would go one better and only bind to the channels that are believed to be analgesic.

Dalichi Sankyo was ready to go all in.They spent big bucks to conduct a worldwide study called ALDAY involving 3600 Fibromyalgia patients in 300 centers from North America, South America, Eastern, and Western Europe, to the Asian Pacific region. So, when their studies failed to produce the desired result the disappointment within the offices was palpable.

Certainly, it wasn’t all bad news for the makers of Mirogabalin. While the medication proved ineffective for Fibromyalgia it did prove effective for those who suffer from the pain of Shingles.

Now, the race is on for the drug manufacturers. Pfizer’s patent on Lyrica is up in 2018 making it open for generic reproduction. Although an alternative may have been found in 4-methylprabalin, which is several times more effective than Lyrica on animals, studies in humans do not appear on the horizon as of this writing.

One such drug (TNX-102) was evaluated by Tonix Pharmaceuticals for use in Fibromyalgia. TNX was evaluated in 4 trials for Fibromyalgia as well as seven other studies. The medication failed in 30% of the Fibromyalgia patients studied. Their site currently is marketing it for PTSD with the focus on the military.

The Henry Ford Health System is currently in Phase 4 of trials for a sleeping medication, Suvorexant (Belsomra), targeting Fibromyalgia. While this medication is said to act on only a small part of the brain and may help with the exhaustion associated with Fibromyalgia the Consumer Reports website claims the risks outweigh the benefits of the new drug.

One of the old standbys in the pharmaceutical field is Propanolol, a beta blocker often used to treat high blood pressure and may be effective for those with Postural Orthostatic Tachycardia Syndrome (POTS). Some medical experts believe it helps with pain and raises cortisol levels in those who have low cortisol levels.

Recent research has shown that patients with Fibromyalgia have an excess of Ateriole-Venule (AV) shunts in the blood vessels of their extremities. These shunts were once thought to be part of regulating blood flow. By studying a patient without pain sensation in the hand they discovered these shunts actually play a part in regulating nerve pain sensation. The discovering of excessive nerve endings in the blood vessels explain the myriad symptoms Fibromyalgia patients experience from deep tissue pain to chronic fatigue. This discovery may well open the doors to new hope in terms of medications and research. Perhaps there is even hope for a cure in the future. 

Also Read: Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): January – March 2017

Reference:

Find more info on Mirogabalin at www.prohealth.com/library/showarticle.cfm?libid=30527

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