Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates,
presented data from a poster presentation at the 66th Annual
Scientific Meeting of the American Headache Society (AHS), held
June 13-16, 2024. A copy of the Company’s poster presentation is
available under the Scientific Presentations tab of the Tonix
website at www.tonixpharma.com.
In the poster presentation titled, “American
Headache Society Consensus Statement and Other Recommendations: How
Many Practitioners Comply With the Recommendations?,” a
retrospective review of real-world data compares real world usage
of non-oral migraine products with the most recent AHS consensus
statement. The data reaffirms several past recommendations from the
AHS and stresses the need for customizing treatment of migraine
headaches to the needs of patients, as well as using the most
appropriate route of administration for any given acute attack
based on the clinical presentation. So far, real world data show
that compliance with the guidelines and the consensus statement
have yet to be achieved but has the potential to be increased.
Specifically, the data show the use of non-oral drugs for treating
an acute migraine attack was only 7% in 2012 and has decreased to
below 4% in 2023, when the potential need for such drugs is
anticipated to be a significant percentage of patients based on
epidemiological data.
“We believe personalizing therapy for migraine
is the future and it is hoped that non-oral medicines will address
some of the persistent dissatisfaction patients experience with
their migraine treatments,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix Pharmaceuticals. “We hope that educating
prescribers about the importance of customized treatments will lead
to enhanced satisfaction and improve the quality of life of
migraine patients. This represents an opportunity for growth in
non-oral first-line therapeutics such Tonix’s Zembrace SymTouch and
Tosymra.”
“Inconsistent and incomplete response to
traditional or emerging oral acute migraine medications continue to
be a burden for individuals living with migraines. We believe that
both Zembrace SymTouch and Tosymra, due to their rapid-onset and
route of administration are well suited to address this unmet
need,” said James Hunter, Executive Vice President of Commercial
Operations at Tonix Pharmaceuticals and President of Tonix
Medicines.
Zembrace SymTouch is the only actively promoted
brand of sumatriptan autoinjector in the U.S. (other sumatriptan
autoinjector products on the market are Imitrex® and generics to
Imitrex®). It has a unique low dose and has demonstrated onset of
migraine pain relief in as few as 10 minutes (17% of patients vs.
5% for placebo)1. Zembrace SymTouch also demonstrated migraine pain
freedom for 46% of patients (vs 27% for placebo) at 2 hours in a
single-attack, double-blind study (N=230)2. Tosymra employs
Intravail® permeation enhancer technology and is
pharmacokinetically equivalent to 4 mg subcutaneous
sumatriptan.3,4, Tosymra delivers migraine pain relief in as little
as 10 minutes with just one spray for some patients (13% vs. 5% for
placebo).1,4,5
About Migraine
Nearly 40 million people in the United States
suffer from migraine6 and it has been recognized as the second
leading cause of disability in the world7. Migraine is
characterized by debilitating attacks lasting four to 72 hours with
multiple symptoms, including pulsating headaches of moderate to
severe pain intensity often associated with nausea or vomiting,
and/or sensitivity to sound (phonophobia) and sensitivity to light
(photophobia)8.
1Mathew NT, et al. Dose ranging efficacy and
safety of subcutaneous sumatriptan in the acute treatment of
migraine. US Sumatriptan Research Group. Arch Neurol.
1992;49(12):1271-1276.
2Landy, S. et al. Efficacy and safety of DFN-11
(sumatriptan injection, 3 mg) in adults with episodic migraine: a
multicenter, randomized, double-blind, placebo-controlled study. J
Headache Pain. 19, 69 (2018).
3Brand-Schieber E, Munjal S, Kumar R, et al.
Human factors validation study of 3 mg sumatriptan autoinjector,
for migraine patients. Med Devices (Auckl). 2016;9:131-137.
4Tosymra [package insert]. Maple Grove, MN:
Upsher-Smith Laboratories, LLC: Feb 2021.
5Wendt J, et al. A randomized, double-blind,
placebo-controlled trial of the efficacy and tolerability of a 4-mg
dose of subcutaneous sumatriptan for the treatment of acute
migraine attacks in adults. Clinical Therapeutics.
2006;28(4):517-526.
6IQVIA 2022 retail sales from the National Sales
Perspectives (NSP) audit within the SMART database estimates
Zembrace sales of ~$19.6 M and Tosymra sales of ~$3.5 M
7GBD 2016 Headache Collaborators. Global,
regional, and national burden of migraine and tension-type
headache, 1990-2016: a systematic analysis for the Global Burden of
Disease Study 2016. Lancet Neurol 2018;17(11):954-976.
8Headache Classification Committee of the
International Headache Society (IHS). The international
classification of headache disorders, 3rd edition. Cephalalgia.
2018;38(1):1–211.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a fully-integrated biopharmaceutical
company focused on developing, licensing and commercializing
therapeutics to treat and prevent human disease and alleviate
suffering. Tonix’s development portfolio is focused on central
nervous system (CNS) disorders. Tonix’s priority is to submit a New
Drug Application (NDA) to the FDA in the second half of 2024 for
Tonmya1, a product candidate for which two statistically
significant Phase 3 studies have been completed for the management
of fibromyalgia. TNX-102 SL is also being developed to treat acute
stress reaction as well as fibromyalgia-type Long COVID. Tonix’s
CNS portfolio includes TNX-1300 (cocaine esterase), a biologic
designed to treat cocaine intoxication that has FDA Breakthrough
Therapy designation and is in Phase 2 development supported by a
grant from the National institute of Drug Abuse. Tonix’s immunology
development portfolio consists of biologics to address organ
transplant rejection, autoimmunity and cancer, including TNX-1500,
which is a humanized monoclonal antibody targeting CD40-ligand
(CD40L or CD154) being developed for the prevention of allograft
rejection and for the treatment of autoimmune diseases. Tonix also
has product candidates in development in the areas of rare disease
and infectious disease. Tonix Medicines, our commercial subsidiary,
markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and
Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute
migraine with or without aura in adults.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
1Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration (FDA) as the tradename for TNX-102 SL
for the management of fibromyalgia. Tonmya has not been approved
for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. All other marks are property of
their respective owners.
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, risks
related to the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; risks related to the failure to
successfully market any of our products; 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 December 31, 2023, as filed
with the Securities and Exchange Commission (the “SEC”) on April 1,
2024, 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
thereof.
Investor Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Katie
DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com(978)
360-3151
Zembrace® SymTouch® (sumatriptan
Injection): IMPORTANT SAFETY INFORMATION
Zembrace SymTouch (Zembrace) can cause
serious side effects, including heart attack and other heart
problems, which may lead to death. Stop use and get emergency help
if you have any signs of a heart attack:
- discomfort in
the center of your chest that lasts for more than a few minutes or
goes away and comes back
- severe
tightness, pain, pressure, or heaviness in your chest, throat,
neck, or jaw
- pain or
discomfort in your arms, back, neck, jaw or stomach
- shortness of
breath with or without chest discomfort
- breaking out in
a cold sweat
- nausea or
vomiting
- feeling
lightheaded
Zembrace is not for people with risk factors for
heart disease (high blood pressure or cholesterol, smoking,
overweight, diabetes, family history of heart disease) unless a
heart exam shows no problem.
Do not use Zembrace if you have:
- history of heart
problems
- narrowing of
blood vessels to your legs, arms, stomach, or kidney (peripheral
vascular disease)
- uncontrolled
high blood pressure
- hemiplegic or
basilar migraines. If you are not sure if you have these, ask your
provider.
- had a stroke,
transient ischemic attacks (TIAs), or problems with blood
circulation
- severe liver
problems
- taken any of the
following medicines in the last 24 hours: almotriptan, eletriptan,
frovatriptan, naratriptan, rizatriptan, ergotamines,
dihydroergotamine.
- are taking
certain antidepressants, known as monoamine oxidase (MAO)-A
inhibitors or it has been 2 weeks or less since you stopped taking
a MAO-A inhibitor. Ask your provider for a list of these medicines
if you are not sure.
- an allergy to
sumatriptan or any of the components of Zembrace
Tell your provider about all of your medical
conditions and medicines you take, including vitamins and
supplements.
Zembrace can cause dizziness, weakness, or
drowsiness. If so, do not drive a car, use machinery, or do
anything where you need to be alert.
Zembrace may cause serious side effects
including:
- changes in color
or sensation in your fingers and toes
- sudden or severe
stomach pain, stomach pain after meals, weight loss, nausea or
vomiting, constipation or diarrhea, bloody diarrhea, fever
- cramping and
pain in your legs or hips; feeling of heaviness or tightness in
your leg muscles; burning or aching pain in your feet or toes while
resting; numbness, tingling, or weakness in your legs; cold feeling
or color changes in one or both legs or feet
- increased blood
pressure including a sudden severe increase even if you have no
history of high blood pressure
- medication
overuse headaches from using migraine medicine for 10 or more days
each month. If your headaches get worse, call your provider.
- serotonin
syndrome, a rare but serious problem that can happen in people
using Zembrace, especially when used with anti-depressant medicines
called SSRIs or SNRIs. Call your provider right away if you have:
mental changes such as seeing things that are not there
(hallucinations), agitation, or coma; fast heartbeat; changes in
blood pressure; high body temperature; tight muscles; or trouble
walking.
- hives (itchy
bumps); swelling of your tongue, mouth, or throat
- seizures even in
people who have never had seizures before
The most common side effects of Zembrace
include: pain and redness at injection site; tingling
or numbness in your fingers or toes; dizziness; warm, hot, burning
feeling to your face (flushing); discomfort or stiffness in your
neck; feeling weak, drowsy, or tired.
Tell your provider if you have any side effect
that bothers you or does not go away. These are not all the
possible side effects of Zembrace. For more information, ask your
provider.
This is the most important information to know
about Zembrace but is not comprehensive. For more information, talk
to your provider and read the Patient
Information and Instructions for Use. You can also
visit www.tonixpharma.com or call 1-888-650-3789.
You are encouraged to report adverse effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
INDICATION AND USAGE
Zembrace is a prescription medicine used to treat acute migraine
headaches with or without aura in adults who have been diagnosed
with migraine.
Zembrace is not used to prevent migraines. It is
not known if it is safe and effective in children under 18 years of
age.
Tosymra® (sumatriptan nasal
spray): IMPORTANT SAFETY INFORMATION
Tosymra can cause serious side effects,
including heart attack and other heart problems, which may lead to
death. Stop Tosymra and get emergency medical help if you have any
signs of heart attack:
- discomfort in
the center of your chest that lasts for more than a few minutes or
goes away and comes back
- severe
tightness, pain, pressure, or heaviness in your chest, throat,
neck, or jaw
- pain or
discomfort in your arms, back, neck, jaw, or stomach
- shortness of
breath with or without chest discomfort
- breaking out in
a cold sweat
- nausea or
vomiting
- feeling
lightheaded
Tosymra is not for people with risk factors for
heart disease (high blood pressure or cholesterol, smoking,
overweight, diabetes, family history of heart disease) unless a
heart exam is done and shows no problem.
Do not use Tosymra if you have:
- history of heart
problems
- narrowing of
blood vessels to your legs, arms, stomach, or kidney (peripheral
vascular disease)
- uncontrolled
high blood pressure
- severe liver
problems
- hemiplegic or
basilar migraines. If you are not sure if you have these, ask your
healthcare provider.
- had a stroke,
transient ischemic attacks (TIAs), or problems with blood
circulation
- taken any of the
following medicines in the last 24 hours: almotriptan, eletriptan,
frovatriptan, naratriptan, rizatriptan, ergotamines, or
dihydroergotamine. Ask your provider if you are not sure if your
medicine is listed above.
- are taking
certain antidepressants, known as monoamine oxidase (MAO)-A
inhibitors or it has been 2 weeks or less since you stopped taking
a MAO-A inhibitor. Ask your provider for a list of these medicines
if you are not sure.
- an allergy to
sumatriptan or any ingredient in Tosymra
Tell your provider about all of your medical
conditions and medicines you take, including vitamins and
supplements.
Tosymra can cause dizziness, weakness, or
drowsiness. If so, do not drive a car, use machinery, or do
anything where you need to be alert.
Tosymra may cause serious side effects
including:
- changes in color
or sensation in your fingers and toes
- sudden or severe
stomach pain, stomach pain after meals, weight loss, nausea or
vomiting, constipation or diarrhea, bloody diarrhea, fever
- cramping and
pain in your legs or hips, feeling of heaviness or tightness in
your leg muscles, burning or aching pain in your feet or toes while
resting, numbness, tingling, or weakness in your legs, cold feeling
or color changes in one or both legs or feet
- increased blood
pressure including a sudden severe increase even if you have no
history of high blood pressure
- medication
overuse headaches from using migraine medicine for 10 or more days
each month. If your headaches get worse, call your
provider.
- serotonin
syndrome, a rare but serious problem that can happen in people
using Tosymra, especially when used with anti-depressant medicines
called SSRIs or SNRIs. Call your provider right away
if you have: mental changes such as seeing things that are
not there (hallucinations), agitation, or coma; fast heartbeat;
changes in blood pressure; high body temperature; tight muscles; or
trouble walking.
- hives (itchy
bumps); swelling of your tongue, mouth, or throat
- seizures even in
people who have never had seizures before
The most common side effects of Tosymra
include: tingling, dizziness, feeling warm or hot, burning
feeling, feeling of heaviness, feeling of pressure, flushing,
feeling of tightness, numbness, application site (nasal) reactions,
abnormal taste, and throat irritation.
Tell your provider if you have any side effect
that bothers you or does not go away. These are not all the
possible side effects of Tosymra. For more information, ask your
provider.
This is the most important information to know
about Tosymra but is not comprehensive. For more information, talk
to your provider and read the Patient
Information and Instructions for Use. You can also
visit www.tonixpharma.com or call 1-888-650-3789.
You are encouraged to report negative side
effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATION AND USAGETosymra is a prescription
medicine used to treat acute migraine headaches with or without
aura in adults.
Tosymra is not used to treat other types of
headaches such as hemiplegic or basilar migraines or cluster
headaches.
Tosymra is not used to prevent migraines. It is
not known if Tosymra is safe and effective in children under 18
years of age.
Tonix Pharmaceuticals (NASDAQ:TNXP)
過去 株価チャート
から 5 2024 まで 6 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
過去 株価チャート
から 6 2023 まで 6 2024