TONMYA

TONMYA is an FDA-registered drug product whose active ingredient is CYCLOBENZAPRINE HYDROCHLORIDE. It is labelled by Tonix Medicines, Inc. taken by sublingual and marketed as a human prescription drug product. Identifiers on file: NDC 70792-102, application NDA219428, label effective 20260814. It is one of 55 FDA drug label records sharing the active ingredient CYCLOBENZAPRINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CYCLOBENZAPRINE HYDROCHLORIDE are most often described in connection with: tonmya indicated, treatment fibromyalgia. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE TONMYA ® is indicated for treatment of fibromyalgia in adults. TONMYA is indicated for the treatment of fibromyalgia in adults ( 1 ).

2 DOSAGE AND ADMINISTRATION Recommended dosage of TONMYA is 5.6 mg administered sublingually once daily at bedtime ( 2.1 ): Starting dose: Days 1 to 14, administer 2.8 mg (1 sublingual tablet) once daily at bedtime. Target dose: Days 15 and thereafter, administer 5.6 mg (2 sublingual tablets) once daily at bedtime. Maximum recommended dosage: 5.6 mg once daily. Ensure mouth is moist with sips of water before sublingual administration ( 2.4 , 5.6 , 6.1 ) Do not swallow whole, cut, crush, or chew ( 2.4 ) Geriatric patients: Recommended dosage is 2.8 mg administered sublingually once daily at bedtime ( 2.2 , 8.5 ) Hepatic impairment (HI): Recommended dosage in patients with mild HI is 2.8 mg administered sublingually once daily at bedtime. Use not recommended in patients with moderate HI or severe HI ( 2.3 , 8.6 ). See important administration instructions in the Full Prescribing Information ( 2.4 , 2.5 , 2.6 ). 2.1 Recommended Dosage The recommended dosage of TONMYA is 5.6 mg administered sublingually once daily at bedtime: Starting dose: Days 1 to 14, administer 2.8 mg (1 sublingual tablet) once daily at bedtime. Target dose: Days 15 and thereafter, administer 5.6 mg (2 sublingual tablets) once daily at bedtime. Maximum recommended dosage: 5.6 mg once daily. 2.2 Recommended Dosage in Geriatric Patients The recommended TONMYA dosage―and the maximum recommended dosage―in geriatric patients is 2.8 mg administered sublingually once daily at bedtime [see Use in Specific Populations (8.5) ]. 2.3 Recommended Dosage in Patients with Hepatic Impairment The recommended TONMYA dosage―and the maximum recommended dosage―in patients with mild hepatic impairment is 2.8 mg administered sublingually once daily at bedtime . TONMYA is not recommended in patients with moderate or severe hepatic impairment [see Use in Specific Populations (8.6) ]. 2.4 Administration Instructions TONMYA is only for sublingual use. Administer after brushing teeth and finishing other oral care and ensure a moist mouth/sublingual area by drinking a few sips of water prior to administration. Place the sublingual tablet(s) under the tongue until dissolved. Do not swallow whole, cut, crush, or chew. Avoid eating or drinking for at least 15 minutes after the sublingual tablet(s) has/have completely dissolved at bedtime and preferably avoid any hot, cold, or acidic beverages until the morning. Avoid talking for at least 5 minutes after administration. 2.5 Recommendations Regarding Missed Dose(s) If you missed a TONMYA bedtime dose, take TONMYA the next evening. Do not take a missed dose during the day. 2.6 Pregnancy Testing Prior to Administration Pregnancy testing is recommended in females of reproductive potential prior to initiating treatment with TONMYA [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ]

4 CONTRAINDICATIONS Hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of a MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. Hyperthyroidism. Hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA ( 4 ) Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation ( 4 ) During acute recovery phase of myocardial infarction and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure ( 4 ) Hyperthyroidism ( 4 )

6 ADVERSE REACTIONS The following clinically significant reactions are described in greater detail, in other sections of this labeling: Embryofetal Toxicity [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Tricyclic Antidepressant-like Adverse Reactions [see Warnings and Precautions (5.3) ] Atropine-like Adverse Reactions [see Warnings and Precautions (5.4) ] CNS Depression [see Warnings and Precautions (5.5) ] Oral Mucosal Adverse Reactions [see Warnings and Precautions (5.6) ] Most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients): oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Tonix Medicines, Inc. at 1-888-869-7633 (1-888-TNXPMED) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of sublingual TONMYA (14 days of 2.8 mg once daily and then 5.6 mg once daily thereafter) is supported by three double-blind, placebo-controlled clinical trials (Trials 1, 2, and 3) in adult patients with fibromyalgia [see Clinical Studies (14) ]. A total of 1,182 patients completed at least 14 weeks of daily treatment, including 580 TONMYA-treated patients (14 days of 2.8 mg once daily and then 5.6 mg once daily thereafter) and 602 placebo-treated patients. Table 1 summarizes the most common adverse reactions in Trials 1, 2, and 3 (≥2% of TONMYA-treated patients and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients). Table 1: Adverse Reactions Reported in ≥2% of TONMYA-Treated Patients and a Higher Incidence than Placebo-Treated Patients in Adult Patients with Fibromyalgia (Trials 1, 2, and 3) Adverse Reactions Placebo (N = 739) TONMYA (N = 735) Oral hypoesthesia Oral hypoesthesia includes hypoesthesia and teeth hypoesthesia 0.7% 23% Oral discomfort Oral discomfort includes tongue discomfort 0.7% 9% Abnormal product taste 0.7% 9% Somnolence Somnolence includes hypersomnia, lethargy, and sedation 2% 6% Oral paresthesia Oral paresthesia includes paresthesia and teeth hyperesthesia 0.4% 6% Oral pain Oral pain includes glossodynia 1% 5% Fatigue Fatigue includes asthenia and lethargy 2% 4% Dry mouth Dry mouth includes dry throat 2% 3% Aphthous ulcer 0.5% 2% Oral Mucosal Adverse Reactions in Trials 1, 2, and 3 In Trials 1, 2, and 3, 43% of TONMYA-treated patients compared to 8% of placebo-treated patients experienced at least 1 treatment-emergent oral mucosal adverse reaction. The most common oral mucosal adverse reactions included oral hypoesthesia, abnormal product taste, oral paresthesia, tongue discomfort, oral discomfort, glossodynia, oral pain, and aphthous ulcer. The majority (82%) of oral mucosal adverse reactions began within minutes of dosing, and of those, 88% occurred after nearly every dose. Almost two-thirds lasted less than 60 minutes. Of the approximately one-third that lasted longer than 60 minutes, 63% were present the next morning. Five patients (0.7% of TONMYA-treated patients) experienced severe oral mucosal adverse reactions, including paresthesia, glossitis, hypoesthesia, oral pain, and dry mouth. Most reactions resolved within days after TONMYA was discontinued. Oral mucosal adverse reactions leading to discontinuation occurred more frequently in TONMYA-treated patients compared to placebo-treated patients (4.5% vs. 0.5%). Adverse Reactions from Other Trials In an open-label, long-term 40 to 52-week safety trial (Trial 4) in an unapproved population of patients previously exposed to 5.6 mg TONMYA once daily (maximum recommended dosage) or placebo, 56 patients were treated with 5.6 mg of TONMYA for at least 1 year. The most common adverse reactions in the TONMYA-treated patients (>5%) were oral hypoesthesia (45%), somnolence (18%), abnormal product taste (7%), and paresthesia oral (7%). In an open-label, long-term 52 week safety trial of adult patients with fibromyalgia previously been exposed to 2.8 mg TONMYA once daily (one half the recommended dosage [see Dosage and Administration (2.1)] ) or placebo (Trial 5), 97 patients were treated for at least 1 year with 2.8 mg of TONMYA once daily. The most common adverse reactions (>5%) in the TONMYA-treated patients were hypoesthesia oral (15%), fatigue (7%), sinusitis (7%), and abnormal product taste (6%). 6.2 Postmarketing Experience The following adverse reactions have been reported in clinical studies or postmarketing experience with cyclobenzaprine immediate-release (IR) products, cyclobenzaprine extended-release (ER) products, or TCAs. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In a postmarketing surveillance program of cyclobenzaprine IR products, the adverse reactions reported most frequently were drowsiness, dry mouth, and dizziness, and adverse reactions reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion. The following adverse reactions have been reported in postmarketing experience with cyclobenzaprine ER products or cyclobenzaprine IR products, in clinical studies of cyclobenzaprine IR products (incidence <1%), or in postmarketing experience with other TCAs: Body as a Whole: Syncope; malaise; chest pain; edema. Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension; hypertension; myocardial infarction; heart block; stroke. Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice, and cholestasis; paralytic ileus, tongue discoloration; stomatitis; parotid swelling. Endocrine: Inappropriate ADH syndrome. Hematologic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia. Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash. Metabolic, Nutritional, and Immune: Elevation and lowering of blood sugar levels; weight gain or loss. Musculoskeletal: Local weakness; myalgia. Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia; serotonin syndrome; neuroleptic malignant syndrome; decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell's palsy; alteration in EEG patterns; extrapyramidal symptoms. Respiratory: Dyspnea. Skin: Sweating; photosensitization; alopecia. Special Senses: Ageusia; tinnitus. Urogenital: Urinary frequency and/or retention; impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.

FDA lists 55 drug label records with CYCLOBENZAPRINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is TONMYA used for?
1 INDICATIONS AND USAGE TONMYA ® is indicated for treatment of fibromyalgia in adults. TONMYA is indicated for the treatment of fibromyalgia in adults ( 1 ).

Who makes TONMYA?
Tonix Medicines, Inc. is the labeler of record for TONMYA. 55 FDA label records share the active ingredient CYCLOBENZAPRINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does TONMYA come in?
administered by sublingual. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is TONMYA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CYCLOBENZAPRINE HYDROCHLORIDE?
Yes. 55 FDA drug label records list CYCLOBENZAPRINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has TONMYA been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.