Tonix Pharmaceuticals (TNXP) thinks it has a drug that can treat fibromyalgia. TNX-102 is an oral tablet that delivers cyclobenzaprine. NIH's page on cyclobenzeprine notes that its commercial names are Amrix and Flexeril, both prescribed short-term to treat muscle spams. The regulatory pathway through the FDA's "pain division" is known thanks to work by competitors. FDA approval for chronic therapy in fibro patients means longer exposures to possible side effects.
The most impressive factor in this company's story right now is the background of their management team. Dr. Seth Lederman has extensive experience in immunology and pharmaceuticals. Other key people on the team have decades of experience with leading drug developers.
The market for fibro drug treatment is quite large. Decision Resources estimates the fibro pain management drug market will grow to US$1.8B in 2018, with the caveat that the entry of a generic version of pregabalin (brand name Lyrica from Pfizer) will drop that figure to US$1.4B immediately thereafter. Tonix's real competition for TNX-102, assuming it passes all FDA hurdles, is therefore a low-priced generic. Pfizer has been milking Lyrica for all it is worth after winning patent exclusivity in 2012, and will continue to do so especially if it can treat epilepsy.
Tonix does have other drugs in its development pipeline. Investors should watch the company's news releases for progress with its FDA studies. It would be relevant to know whether TNX-102 is more effective at suppressing fibro symptoms than pregabalin, with fewer side effects, at lower costs. Two out of those three would give it a marketable case against a generic.
Full disclosure: No position in TNXP or other companies mentioned at this time.
