Tonix Pharmaceuticals (NASDAQ:TNXP) is developing TNX-102 SL, a sublingual formulation of cyclobenzaprine for two large indications, fibromyalgia and post-traumatic stress disorder (PTSD). The fibromyalgia program is the most advanced and we expect a read out of Phase III data in Q316. Due to previous data and clinical trial design improvements over its Phase IIb BESTFIT trial, we believe Phase III has a high chance of success. Data from a proof-of-concept Phase II trial in PTSD is expected in Q216, although we view this as very high risk because it is an exceptionally difficult indication.
TNX-102 SL: A better and safer cyclobenzaprine
TNX-102 SL is a low-dose sublingual formulation of cyclobenzaprine, a muscle relaxant that has been approved for almost 40 years for the treatment of muscle spasms. A much cleaner safety profile without the next day somnolence should assist adoption.
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