New Fibromyalgia Medications: One Gets Fast-Tracked, Another Fails

IMC-1:

The U.S .Food and Drug Administration (FDA) has granted Fast Track Designation for this new treatment for fibromyalgia. This medication has been studied in a randomized, double-blind, placebo controlled phase 2 study which showed improvement in fibromyalgia symptoms. This potential fibromyalgia medication is a combination of famciclovir, an antiviral agent, with celecoxib, an anti-inflammatory. Phase three trials for this new fibromyalgia treatment may start next year. Dr. William Pridgen, CEO and founder of Innovative Med Concepts, has suggested that ‘IMC-1 has a novel mechanism of action designed to suppress chronic tissue –resident herpes virus, which may have a role in triggering the maintaining the symptoms of fibromyalgia”.

Mirogabalin:

This potential fibromyalgia treatment, which is similar to gabapentin (Neurontin) and pregabalin (Lyrica), binds to the body’s calcium channels, however, with higher selectivity than pregabalin, and thus with potentially less side effects. This medication has been studied with promising results in two Phase II, randomized, double blind, placebo controlled studies for diabetic peripheral neuropathic pain (DPNP). Phase three studies are ongoing with at least 1,000 fibromyalgia sufferers, comparing mirogabalin with pregabalin for the relief of fibromyalgia pain.

TNX-102 SL (cyclobenzaprine HCL):

This is a sublingual (dissolving under the tongue) formulation of cyclobenzaprine that acts against several receptors in pain, sleep and stress. Phase Two clinical trials indicated that 30% or higher experienced less pain and more physical function and sleep quality according to criteria by the Outcome Measures in Rheumatology. Unfortunately, Phase Three clinical trials failed to meet goals for reducing fibromyalgia pain and the medication is now being evaluated for treatment of PTSD (post traumatic stress disorder).

TD-9855:

This is a norepinephrine and serotonin reuptake inhibitor which showed promise in a phase II study as a fibromyalgia treatment. However, Theravance Biopharma shifted their focus and is now recruiting for a multi-center, randomized, double-blind study conducted in male and female subjects with neurogenic orthostatic hypotension to evaluate the effectiveness of TD-9855 with the symptoms of orthostatic intolerance such as sweating, fatigue, headache, visual disturbance, and nausea.

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