ProActive Capital Resources Group has received compensation from TONIX, to provide research and investor relations coverage for a period of time.
Tonix Pharma (NASDAQ:TNXP) is a specialty pharmaceutical company focused on the development of improved formulations of drugs for common central nervous system (NYSE:CNS) disorders such as lead product candidates TNX-102 andTNX-105 which are based on the widely used muscle relaxant drug cyclobenzaprine (aka FLEXERIL, AMRIX and FEXMID).
TNX-102 SL is a sublingual (under the tongue) low-dose (2.4mg) formulation of cyclobenzaprine with a pivotal Phase 3 clinical trial expected to begin early next year for the treatment of fibromyalgia (to help restore normal sleep patterns), which affects an estimated 5 million Americans according to National Institute of Health (NIH) stats and represents a US market opportunity of $1.4 billion. The Company recently announced the results of Phase 2 clinical trials demonstrating a faster onset via sublingual administration along with reduced levels of a metabolite (norcyclobenzaprine) compared to standard table formulations of the drug.
Cyclobenzaprine is widely used off-label for the treatment of fibromyalgia so there is a significant market opportunity for $TNXP to develop an improved version of the drug and perform pivotal Phase 3 testing to obtain formal FDA approval for this indication. $TNXP has demonstrated lower levels of norcyclobenzaprine that support long-term dosing at bedtime for the Company's sublingual formulation (TNX-102) since this metabolite is known to have activity and accumulates over time.
$TNXP is also developing TNX-105 as an additional very low dose cyclobenzaprine (VLDC) novel formulation for the management of post-traumatic stress disorder (PTSD) and plans to conduct a proof-of-concept clinical trial during the first half of 2013. The Company expects to complete the first of two planned pivotal Phase 3 trials for TNX-102 during 1H14 and plans to seek a partnership for the second pivotal study and commercialization.
Given the demonstrated advantages for lead product candidateTNX-102 and the greatly reduced clinical risk as an improved formulation of an existing drug; shares of $TNXP are poised to gain attention from traders in the biomedical space as the Phase 3 trial begins given the substantial market opportunity in the lead indication for fibromyalgia.