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Cyclobenzaprine hydrochloride 2%
Cyclobenzaprine is a centrally acting muscle relaxant that reduces muscle tension by depressing activity in the brainstem.
Cyclobenzaprine is a centrally acting muscle relaxant that reduces muscle tension by depressing activity in the brainstem. Used for Acute musculoskeletal pain and muscle spasms (topical formulation in Phase 2).
At a glance
| Generic name | Cyclobenzaprine hydrochloride 2% |
|---|---|
| Also known as | Cyclobenzaprine hydrochloride |
| Sponsor | Express Specialty Pharmacy |
| Drug class | Muscle relaxant (centrally acting) |
| Modality | Small molecule |
| Therapeutic area | Musculoskeletal/Pain Management |
| Phase | Phase 2 |
Mechanism of action
Cyclobenzaprine works primarily through central nervous system depression, acting on the brainstem to reduce motor neuron activity and muscle tone. It is structurally related to tricyclic antidepressants and may have some noradrenergic activity. The drug is used to relieve muscle spasms associated with acute musculoskeletal conditions.
Approved indications
- Acute musculoskeletal pain and muscle spasms (topical formulation in Phase 2)
Common side effects
- Drowsiness
- Dizziness
- Dry mouth
- Fatigue
- Headache
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)
- 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)
- A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients (NA)
- 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients (PHASE3)
- A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD (PHASE3)
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 |
|---|---|
| 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:
- Cyclobenzaprine hydrochloride 2% CI brief — competitive landscape report
- Cyclobenzaprine hydrochloride 2% updates RSS · CI watch RSS
- Express Specialty Pharmacy portfolio CI