Tonix Pharmaceuticals Completes Positive Pre-IND Meeting with FDA for TNX-102 SL (Cyclobenzaprine HCI Sublingual Tablets) as ...
December 12 2017 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company that is developing innovative pharmaceutical and biological
products to address public health challenges and diseases with
significant unmet needs, announced today that it recently
held a pre-Investigational New Drug (IND) meeting with the U.S.
Food and Drug Administration (FDA) to discuss its proposed
development of TNX-102 SL*, the Company's patented sublingual
tablet formulation of cyclobenzaprine hydrochloride (CBP) for
bedtime use for the treatment of agitation in Alzheimer’s disease
(AAD). TNX-102 SL is currently in Phase 3 development for the
treatment of posttraumatic stress disorder (PTSD).
Seth Lederman, M.D., President and Chief Executive Officer of
Tonix, stated, "We are excited by our positive dialogue with FDA
regarding the potential clinical utility of TNX-102 SL for
agitation in Alzheimer’s disease. Based on FDA’s feedback, Tonix
has the data needed to file an IND to support a potentially pivotal
efficacy study. We plan to submit the TNX-102 SL IND for agitation
in Alzheimer’s disease in the first quarter of 2018."
Dr. Lederman continued, "We believe TNX-102 SL has the potential
to treat agitation in Alzheimer’s disease by improving sleep
quality. It is anticipated that the development and approval of
TNX-102 SL for agitation in Alzheimer’s disease will benefit from
the development program for PTSD. While initial NDA approval of
TNX-102 SL for the treatment of PTSD, Tonmya®, remains our highest
priority development program, we are also interested in exploring
the clinical utility of TNX-102 SL in other indications and
agitation in Alzheimer’s disease is at the top of that list.”
Dr. Gregory Sullivan, Chief Medical Officer of Tonix stated,
“Agitation in dementia, dementia and moderate cognitive impairment
are all associated with sleep disruption. The proposed sleep
quality improvement mechanism of TNX-102 SL, coupled with its low
dosage strength and bedtime dosing regimen makes it an ideal drug
candidate to be investigated in agitation in Alzheimer’s disease.
The development of TNX-102 SL for agitation in Alzheimer’s is part
of our effort to investigate the proposed sleep quality improvement
mechanism of TNX-102 SL in a number of established
neuro-psychiatric disorders which are significant unmet needs.”
*TNX-102 SL 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
(cyclobenzaprine HCl sublingual tablets) for PTSD.
About Agitation in Alzheimer’s Disease
Agitation in Alzheimer’s disease is associated with significant
negative consequences for both patients as well as their
caregivers. Development of agitation, or its worsening, is one of
the most common reasons for patients having to transition to
nursing homes and other long-term care settings. Currently, there
is no FDA approved treatment for behavioral symptoms such as
agitation and aggression which affects the quality of life of both
the patients and caregivers1. Sleep disturbances and agitation are
common and co-morbid features of Alzheimer’s disease.2 Currently
there is widespread off-label use of atypical anti-psychotic
medications for behavioral symptoms in Alzheimer’s disease, despite
the lack of evidence for their effectiveness and significant risks
associated with their use in this population.3 Behavioral symptoms
are a major clinical complication of Alzheimer’s disease. They are
estimated to be present in as many as 50 percent of
community-dwelling patients, and as many as 80 percent of nursing
home residents. Agitation, which includes emotional lability,
restlessness, irritability, and aggression, is one of the most
distressing and debilitating of these behavioral complications of
Alzheimer’s disease. Agitation is likely to affect more than half
of the 5.3 million Americans who currently suffer from Alzheimer’s
disease, and this number is expected to nearly triple by 2050.1 The
presence of agitation nearly doubles the cost of caring for
patients with Alzheimer’s disease, and agitation is estimated to
account for more than 12 percent of the $256 billion in healthcare
and societal cost of associated with Alzheimer’s disease for the
year 2017 in the United States.1
1The Alzheimer’s Association, 2017 Alzheimer’s Disease Facts and
Figures: https://www.alz.org/facts/2Rose, K. et al. (2015).
American Journal of Alzheimer's Disease & Other
Dementias, 30:783Greenblatt, H. K., & Greenblatt, D. J.
(2016). The Journal of Clinical Pharmacology, 56:1048
About TNX-102 SL
TNX-102 SL is a patented sublingual tablet formulation of
cyclobenzaprine hydrochloride which provides rapid transmucosal
absorption and reduced production of a long half-life active
metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic
metabolism. 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 and biological
products to address major public health challenges and diseases
with significant unmet needs. Tonix’s lead product candidate,
Tonmya, is in Phase 3 development as a bedtime treatment for PTSD.
TNX-601 (tianeptine oxalate) is in the pre-IND application stage,
also for the treatment of PTSD but designed for daytime dosing.
Tonix is also developing TNX-801, a potential smallpox-preventing
vaccine based on a live synthetic version of horsepox virus,
currently in the pre-IND application stage.
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 periodic reports filed with the SEC on or after the
date thereof. 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 Morris (investors)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Rich Allan (media)Russo
Partnersrich.allan@russopartnersllc.com(646) 942-5588
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