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Amrix (CYCLOBENZAPRINE)
Amrix (CYCLOBENZAPRINE) is a small molecule muscle relaxant that targets the histamine H1 receptor. Originally developed and currently owned by Janssen Research and Development, it was FDA-approved in 1977 for the treatment of spasticity. As an off-patent medication, Amrix is available from multiple generic manufacturers. Key safety considerations include its 18-hour half-life and 55% bioavailability. Amrix is a valuable option for managing spasticity, with a well-established commercial status.
At a glance
| Generic name | CYCLOBENZAPRINE |
|---|---|
| Sponsor | Janssen Res And Dev |
| Drug class | Muscle Relaxant |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1977 |
Approved indications
- Spasticity
Common side effects
- Dry mouth
- Dizziness
- Nausea
- Dyspepsia
- Fatigue
- Somnolence
- Constipation
- Vomiting
- Anorexia
- Diarrhea
- Gastrointestinal pain
- Gastritis
Drug interactions
- fluoxetine
- paroxetine
- phenelzine
- rasagiline
- tramadol
- tranylcypromine
Key clinical trials
- A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects (PHASE1)
- Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction (PHASE2,PHASE3)
- A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants (PHASE1)
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
- Multimodal Analgesia Effect on Post Surgical Patient (PHASE4)
- Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) (PHASE2)
- Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study (PHASE4)
- A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Amrix CI brief — competitive landscape report
- Amrix updates RSS · CI watch RSS