Blog Exposure – Tonix Pharma Announces 50% Enrolment in Tonmya® Study for PTSD

Stock Monitor: China Pharma Holdings Post Earnings Reporting

LONDON, UK / ACCESSWIRE / April 05, 2018 / Active-Investors.com has just released a free research report on Tonix Pharma Holding Corp. (NASDAQ: TNXP) (“Tonix”). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=TNXP as the Company’s latest news hit the wire. On April 03, 2018, the Company announced that 50% of the planned total number of participants have been randomized in the Phase-3 HONOR study evaluating Tonmya®, or TNX-102 SL 5.6 mg, for the bedtime treatment of military-related post-traumatic stress disorder (PTSD). Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is currently working on the research report for China Pharma Holdings, Inc. (NYSE AMER: CPHI), which also belongs to the Healthcare sector as the Company Tonix Pharma Holding. Do not miss out and become a member today for free to access this upcoming report at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Tonix Pharma Holding most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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Breakthrough Therapy

Tonmya® has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA) for the treatment of PTSD. The clinical evidence from the Phase-2 study of Tonmya® showed a potential improvement over existing therapies used to treat military-related PTSD. The FDA is committed to expediting the development and review of Tonmya® for PTSD.

Tonmya® has been conditionally accepted by the FDA as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for PTSD.

Tonmya® and the Phase-3 HONOR Study

Tonmya® is a sublingual transmucosal tablet formulation of cyclobenzaprine that is in Phase-3 development. PTSD is a serious condition characterized by chronic disability, inadequate treatment options, especially for military-related PTSD, and an overall high utilization of healthcare services that contributes to significant economic burdens.

In a Phase-2 study, Tonmya® 5.6 mg was found to be effective in treating military-related PTSD, which formed the basis of the Breakthrough Therapy designation granted by the FDA. Tonix is currently conducting a Phase-3 HONOR study in the US, which is a 12-week randomized, double-blind, placebo-controlled trial evaluating the efficacy of Tonmya® 5.6 mg in participants with military-related PTSD. This two-arm, adaptive-design trial is targeting enrolment of up to approximately 550 participants in approximately 40 US sites.

An unblinded interim analysis will be conducted now that the study has accumulated efficacy results from approximately 275 randomized participants. Tonix noted that in a Cross-Disciplinary Breakthrough Therapy meeting, the FDA confirmed that a single-study NDA approval could be possible if the top-line data from the HONOR study are statistically very persuasive, and an additional abuse assessment study is not required for the NDA filing.

The Way Forward

Tonix stated that an interim analysis of the first 50% of randomized participants will be conducted shortly after the 12-week treatment period is completed by these participants. The top-line efficacy results from the interim analysis are expected in Q3 2018.

The interim analysis will be studied by an Independent Data Monitoring Committee (IDMC) which will review unblinded data from this first 50% of participants and make one of the three following recommendations: (1) stop the trial for success; (2) continue to enroll the full study as planned; or (3) continue to enroll with a specified increase in the total number of participants in the full study.

Tonix stated its preparedness to file an NDA for Tonmya® for the treatment of PTSD in 2019, in the event of a persuasive outcome of the HONOR study.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical organization focused on discovering and developing pharmaceutical products to treat serious neuropsychiatric conditions, and biological products to improve biodefense through potential medical counter-measures.

Stock Performance Snapshot

April 04, 2018 – At Wednesday’s closing bell, Tonix Pharma’s stock rose 1.75%, ending the trading session at $2.90.

Volume traded for the day: 105.14 thousand shares, which was above the 3-month average volume of 66.29 thousand shares.

After yesterday’s close, Tonix Pharma’s market cap was at $22.24 million.

The stock is part of the Healthcare sector, categorized under the Drug Manufacturers – Major industry. This sector was up 1.4% at the end of the session.

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