The preliminary results of the study showed no significant effect of a fatty meal on the rate or extent of absorption of TNX-102 SL 5.6 mg administered as 2 x 2.8 mg sublingual tablets. The absence of a food effect is consistent with transmucosal absorption after sublingual administration. Oral cyclobenzaprine products approved for treating muscle spasm have significant increases in absorption with food. Food effects which change plasma drug levels can add unpredictability for patients in terms of therapeutic benefits or side effects. The study also showed the rate and extent of absorption of cyclobenzaprine increase in a dose proportional manner from 2.8 mg to 5.6 mg for TNX-102 SL. The dose proportionality observed in this study confirms an earlier study using a prototype 2.4 mg formulation.
About
Tonix is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat psychiatric, pain and addiction conditions. Tonix's lead product candidate, TNX-102 SL, is in Phase 3 development as a bedtime treatment for PTSD (trade name Tonmya) and fibromyalgia. The Phase 3 RECOVERY trial (P302) in PTSD is currently enrolling and results from an interim analysis for a potential sample size adjustment are expected in the first quarter of 2020 and topline data are expected in the second quarter of 2020 if the sample size remains the same. TNX-102 SL for PTSD has
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.
Tonmya has been conditionally accepted by the FDA as the proposed trade name for TNX-102 SL for the treatment of PTSD.
TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is an investigational new biologic and has not been approved for any indication.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as 'anticipate,' 'believe,' 'forecast,' 'estimate,' 'expect,' and 'intend,' among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended
Contact:
Tel: (212) 688-9421
Email: investor.relations@tonixpharma.com
(C) 2020 Electronic News Publishing, source