Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya® as Proposed Brand Name for TNX-102 SL (Cyclobenzaprine HCl...
July 06 2017 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix) a company
that is developing innovative pharmaceutical products to address
public health challenges today reported that the U.S. Food and Drug
Administration (FDA) has conditionally accepted the proposed trade
name Tonmya (ton-MY-ah) for TNX-102 SL* (cyclobenzaprine HCl
sublingual tablets) for the management of posttraumatic stress
disorder (PTSD). Tonix recently launched the Phase 3 HONOR study of
Tonmya in military-related PTSD, from which topline results are
expected to be reported in the second half of 2018. Tonmya was
designated a Breakthrough Therapy by the FDA for the treatment of
PTSD.
A request for proprietary name review for Tonmya
will be submitted once the PTSD New Drug Application (NDA) is
submitted. FDA's final approval of Tonmya is subject to NDA
approval. A request for review of Tonmya as the proposed name for
TNX-102 SL for the management of fibromyalgia has been withdrawn at
the FDA. The U.S. Patent and Trademark Office has granted the
federal registration of the Tonmya mark.
*TNX-102 SL (cyclobenzaprine HCl sublingual
tablets)/Tonmya is an investigational new drug and has not been
approved for any indication.
About Tonmya and the Phase 3 HONOR Study
Tonmya (cyclobenzaprine HCl sublingual tablets) is a patented
sublingual transmucosal 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 (2 x 2.8 mg tablets),
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 trial of Tonmya in
military-related PTSD in the United States, the HONOR study, 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 enrollment of up to approximately 550 participants across
approximately 35 clinical sites. An unblinded interim analysis will
be conducted once the study has accumulated efficacy results from
approximately 275 randomized participants. In a recent
Cross-Disciplinary Breakthrough Therapy meeting, the FDA confirmed
that a single-study NDA approval could be possible if the topline
data from the HONOR study are statistically very persuasive.
Additional details of the HONOR study are available at
www.thehonorstudy.com or
https://clinicaltrials.gov/ct2/show/NCT03062540. The U.S. Patent
and Trademark Office has issued a patent (U.S. Patent No.
9,636,408) protecting the composition and manufacture of the unique
Tonmya formulation. The Protectic™ protective eutectic and
Angstro-Technology™ formulation claimed in the patent are important
elements of Tonix’s proprietary Tonmya composition. This patent is
expected to provide Tonmya, upon NDA approval, with U.S. market
exclusivity until 2034.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical products to
address major public health challenges. In addition to Tonmya for
PTSD, Tonix is developing TNX-601 (tianeptine oxalate), a clinical
candidate at pre-IND (Investigational New Drug) application stage,
designed as a daytime treatment for PTSD and TNX-801, a live
synthetic version of horsepox virus, at the pre-IND application
stage, to be developed as a potential smallpox-preventing
vaccine.
This press release and further information about Tonix can be
found at www.tonixpharma.com.
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,
substantial competition; 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 risks
related to failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations. 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
December 31, 2016, as filed with the Securities and Exchange
Commission (the “SEC”) on April 13, 2017, and future periodic
reports filed with the SEC on or after the date hereof. All of
Tonix's forward-looking statements are expressly qualified by all
such risk factors and other cautionary statements. The information
set forth herein speaks only as of the date hereof.
Contacts
Jessica Smiley
Investor Relations
investor.relations@tonixpharma.com
(212) 980-9155 x18
Russo Partners (media)
Rich Allan
rich.allan@russopartnersllc.com
(646) 942-5588
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