Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP 8-K
Tonix Pharmaceuticals Announces FDA
Approval of TonmyaTM (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia
first FDA-approved therapy for the treatment of fibromyalgia in over 15 years
is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women
3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated
Commercial availability
of Tonmya is expected in the fourth quarter
webcast and conference call on Monday August 18, 2025 at 8:30 AM ET
CHATHAM, N.J., August 15, 2025 (GLOBE
NEWSWIRE) --Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that the U.S.
Food and Drug Administration (FDA) approved TonmyaTM (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia
in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation
that is designed for rapid absorption into the bloodstream. Tonmya is the first new FDA-approved therapy for the treatment of fibromyalgia
"The FDA approval of Tonmya as
a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating
pain this condition causes," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "At Tonix, we recognized
the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition (COPC), that
has gone without innovation for many years. We are hopeful that effectively treating pain with Tonmya could help improve the lives of
people with this chronic syndrome."
"The chronic pain of fibromyalgia
is debilitating to every aspect of a person's life, including causing sleep disturbance and fatigue, all of which can negatively
impact someone's ability to carry out their daily activities," said Sharon Waldrop, a person with lived experience and founder
of the Fibromyalgia Association. "For over 15 years, this community has been underserved and waiting for new treatment options.
This approval is a promising step forward and brings renewed hope to millions."
approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients
in total that evaluated Tonmya as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, Tonmya significantly reduced daily
pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya
experienced a clinically meaningful (30%)
improvement in their pain after three months, compared to placebo.
Across three Phase 3 clinical trials
with over 1,400 patients evaluated, Tonmya was generally well tolerated. The most common adverse events (incidence 2% and at a higher
incidence in Tonmya-treated patients compared to placebo-treated patients) included oral hypoesthesia (numbness in the mouth), oral discomfort,
abnormal product taste, somnolence (drowsiness), oral paresthesia (tingling, pricking or burning in the mouth), oral pain, fatigue, dry
mouth, and aphthous ulcer (canker sore).
"For many years, rheumatologists
like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment
needs for the majority of patients," said Philip Mease, M.D., Director of Rheumatology Research at the Providence Swedish Medical
Center and Clinical Professor at the University of Washington School of Medicine. "Tonmya is a novel treatment approach that targets
nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain."
The latest Phase 3 trial, RESILIENT, was recently published
in Pain Medicine with data on primary and secondary endpoints measuring pain, patient's global impression of change, patient-reported
symptoms and function, sleep disturbance, and fatigue.
"I know firsthand how the chronic
pain of fibromyalgia significantly disrupts my patients' lives." Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology,
Pain, and Perioperative Medicine at The University of Kansas Health System. "Treatments that are processed through the liver can
result in metabolites that could affect a medicine's efficacy and safety over time. Tonmya is administered sublingually which is
designed to reduce pain quickly and durably with a tolerable safety profile."
Tonix thanks the participants and investigators
involved in its fibromyalgia clinical trials, and FDA for its commitment to approving new treatments for this condition.
Tonmya is expected to be available for
adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of this year.
For more information, visit TonmyaHCP.com
or download the TONMYA Fact Sheet here.
Tonix will host a webcast and conference call on Monday, August
18 at 8:30 AM ET to discuss the approval of Tonmya. The live webcast of the call will be available on the Investors section of Tonix's
website: https://ir.tonixpharma.com/news-events/ir-events. To participate by phone, please register
in advance using this link to obtain a local or toll-free phone number and your personal pin. A replay
of the webcast will be available for approximately 90 days following the live event. The slides presented during the webcast will be
made available on the "Presentations" page of the "Investors" section of the Company's website.
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous
system. Fibromyalgia afflicts an estimated 10 million adults in the U.S., approximately 80% of whom are women. Symptoms of fibromyalgia
include chronic widespread pain, nonrestorative sleep (waking up tired and unrefreshed), fatigue, and morning stiffness. Other associated
symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia
struggle with their daily activities, have impaired quality of life, and frequently are disabled. Patients with fibromyalgia have double
the medical costs compared to the general population in the U.S.
TonmyaTM (cyclobenzaprine HCl sublingual tablets)
Tonmya, which was investigated as 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. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities
at the 5-HT2A serotonergic, 1-adrenergic,
H1-histaminergic, and M1-muscarinic receptors, Tonmya is now approved as a once-daily bedtime treatment for fibromyalgia in adults. The
United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018,
Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic protective
eutectic and Angstro-Technology formulation claimed in the patent are important elements of Tonix's proprietary composition.
These patents are expected to provide Tonmya with U.S. market exclusivity until 2034. Pending patent applications related to method of
use could extend exclusivity until 2044.
About the Phase 3 Clinical Trials: RELIEF
The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled
trials designed to evaluate the efficacy and safety of TonmyaTM (cyclobenzaprine hydrochloride sublingual tablets) for the
treatment of fibromyalgia. RELIEF and RESILIENT were two-arm trials that enrolled 503 and 457 adults with fibromyalgia across 40 and
33 United States sites, respectively. In both trials, the first two weeks of treatment consisted of a run-in period in which participants
started on Tonmya 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to Tonmya 5.6 mg (2 x 2.8 mg tablets)
or two placebo tablets for the remaining 12 weeks. The primary endpoint across both trials was the daily diary pain intensity score change
(Tonmya 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores). Additional
details on RELIEF (NCT04172831) and RESILIENT (NCT05273749) are available
on clinicaltrials.gov.
RALLY was a replicate Phase 3 trial to RELIEF and RESILIENT that
demonstrated greater but non-significant treatment effect with Tonmya compared to placebo and demonstrated consistent safety. Results
of this trial may not have been generalizable due to the presence of factors outside the conduct of the study. Additional details are
available on clinicaltrials.gov (NCT04508621).
Tonix Pharmaceuticals Holding Corp.
Tonix is a fully-integrated biotechnology company. Tonix's development portfolio is focused on central nervous system (CNS) disorders,
immunology, immuno-oncology and infectious diseases. Tonix owns and operates a state-of-the art infectious disease research facility in
Frederick, MD. Tonix Medicines, Inc., our wholly-owned commercial subsidiary, markets treatments for fibromyalgia and acute migraine.
This press release and further information about Tonix can be found
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,"