TONMYA

Following single-dose sublingual administration of 2.8 mg and 5.6 mg of TONMYA in healthy adult subjects (n=16), C max , AUC 0-tau, and AUC 0-inf of cyclobenzaprine increased in an approximately dose-proportional manner. In a multiple-dose study of 5.6 mg of TONMYA administered sublingually once daily for 20 days in healthy subjects (n=26), approximately 2.5-fold accumulation of plasma cyclobenzaprine exposure was observed at steady-state.

AbsorptionThe median time to peak plasma cyclobenzaprin...

The efficacy of TONMYA for the treatment of fibromyalgia was assessed in three randomized, two-arm, parallel-group, double-blind, placebo-controlled multicenter trials (Trial 1 [NCT04172831], Trial 2 [NCT04508621], and Trial 3 [NCT05273749]). The trials enrolled 1,474 patients aged 18 to 65 (735 TONMYA-treated patients and 739 placebo-treated patients) who met the 2016 American College of Rheumatology (ACR) criteria for diagnosis of fibromyalgia (including generalized pain, defined as pain in at least 4 of 5 regions; symptoms that had been present at a similar level for at least 3 months; and ...

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 Precaution...

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 seiz...

Embryofetal Toxicity : Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and through the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. ( 5.1 , 8.1 , 8.3 ) Serotonin Syndrome: Potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine when used in combination with other drugs. Immedia...

7 DRUG INTERACTIONS Based on its structural similarity to TCAs, concomitant use of TONMYA with: MAO inhibitors may be life-threatening [see Contraindications (4) ] , Alcohol, barbiturates, and other CNS depressants may increase the risk of adverse reactions associated with these drugs, Tramadol may increase the seizure risk, Guanethidine or other similar acting drugs may block the antihypertensive...