Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Tonix Pharmaceuticals Announces Commitment
to Supply Tosymra (sumatriptan Nasal Spray) 10 mg for Treatment of Acute Migraine to Meet Potential Increased Demand Following GSK's
Planned Discontinuation of Imitrex (sumatriptan) Nasal Spray After January 2024
Tosymra Nasal Spray 10 mg is a Proprietary Acute
Migraine Treatment Approved Under the 505(b)2 Pathway Based on Bioequivalence to Imitrex (sumatriptan) Injection 4 mg
GlaxoSmithKline Recently Notified FDA that it will
Discontinue Imitrex Nasal Spray 5 mg and 20 mg Products after January 2024
CHATHAM, N.J., September 6, 2023 (GLOBE NEWSWIRE)
- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with
marketed products and a pipeline of development candidates, today announced that it is committed to meeting potential increased
demand for Tosymra (sumatriptan) nasal spray 10 mg after GlaxoSmithKline's (GSK) planned discontinuation of Imitrex (sumatriptan)
nasal spray 5 mg and 20 mg products after January, 2024.
On August 8, 2023, GSK informed the U.S. Food
and Drug Administration (FDA) of its plan to discontinue Imitrex nasal spray 5 mg and 20 mg doses after January 31, 2024. The notification
is posted on the FDA Drug Shortages website.1 Tonix is preparing for potential increased demand for Tosymra (sumatriptan nasal
spray) 10 mg to help avoid possible drug shortages for patients who suffer from migraines. Tosymra nasal spray is approved on the basis
of bioequivalence to Imitrex injection 4 mg.
Drug shortages have presented an ongoing challenge
for the U.S. healthcare system, reaching near-record levels2 in recent months, causing treatment delays and rationing. Tonix
is ready to step in to alleviate potential shortages in sumatriptan, a widely used treatment option for acute migraine.
"In response to FDA outreach, we have
confirmed our commitment to meet potential increased demand for sumatriptan nasal spray from patients who suffer from migraines,"
said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "While Tosymra nasal spray and Imitrex nasal spray are
not substitutable at the pharmacy, we plan to alert providers to the possibility of prescribing Tosymra for patients who may benefit from
a nasal spray formulation of sumatriptan."
The American Headache Society Consensus Statement
on migraine treatments recommends that "a non-oral formulation should be used in patients whose attacks are associated with severe
nausea or vomiting, who do not respond well to traditional oral treatments, or who have trouble swallowing orally administered medications."3
Approximately 73% of migraine patients have been reported to experience nausea with or without vomiting during their attacks.4
"Intranasal sumatriptan is an important
therapy for those who suffer from migraines. We believe Tosymra is differentiated from other intranasal formulations of sumatriptan, which
are generic equivalents to Imitrex nasal spray because of its proprietary Intravail absorption enhancer technology," said James
Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines. "Intravail
technology helps the medication absorb into the bloodstream so it can work quickly, providing migraine pain relief in as little as 10
minutes for some patients."5,6,7
Nearly 40 million people in the United States
suffer from migraine8 and it has been recognized as the second leading cause of disability in the world.9 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).
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing,
developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial
subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray)
10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023.
Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix's development
portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix's
CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.
Tonix's lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with
topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic
post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in
the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed
as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter
of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small
molecule oral therapeutic in preclinical development to treat MDD, Alzheimer's disease and Parkinson's disease. Relative to
tianeptine, estianeptine lacks activity on the -opioid receptor while maintaining activity in the rat Novel Object Recognition
test in vivo and the ability to activate PPAR- / and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated
oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept
study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity
and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed
to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected
to be initiated in the third quarter of 2023. Tonix's rare disease development portfolio includes TNX-2900 (intranasal potentiated
oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix's immunology
development portfolio includes 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. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix's infectious
disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine
platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes
TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*Tonix's product development candidates are
investigational new drugs or biologics and have not been approved for any indication.
1FDA Drug Shortage, accessed Aug 24, 2023 - https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sumatriptan+Nasal+Spray&st=d&tab=tabs-2
2CNN, accessed September 1, 2023 - https://www.cnn.com/2023/08/10/health/drug-shortage-pharmacist-survey/index.html
3Ailani J, et al. Headache. 2021. 61: 1021-1039
4Newman LC. Headache. 2013. 53 Suppl 1:11-6
5Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories,
6Mathew NT, et al. Arch Neurol. 1992. 49(12):1271-6
7Wendt J, et al. Clinical Therapeutics. 2006. 28(4):517-526
8Burch RC, et al. Neurol Clin. 2019. 37(4):631-649
9Steiner TJ, et al. J Headache Pain. 2020.
Zembrace SymTouch and Tosymra are registered trademarks
of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. 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, 2022, as filed with the Securities and Exchange Commission (the "SEC") on March 13, 2023, and periodic