Overview
Cyclobenzaprine, a centrally-acting muscle relaxant, was first synthesized in 1961 and has been available for human use since 1977. It was initially studied for use as antidepressant given its structural similarity to tricyclic antidepressants - it differs from Amitriptyline by only a single double bond. Since its approval, it has remained relatively popular as an adjunctive, short-term treatment for acute skeletal muscle spasms secondary to musculoskeletal injury.
Background
Cyclobenzaprine, a centrally-acting muscle relaxant, was first synthesized in 1961 and has been available for human use since 1977. It was initially studied for use as antidepressant given its structural similarity to tricyclic antidepressants - it differs from Amitriptyline by only a single double bond. Since its approval, it has remained relatively popular as an adjunctive, short-term treatment for acute skeletal muscle spasms secondary to musculoskeletal injury.
Indication
用于缓解与急性疼痛的肌肉骨骼疾病相关的肌肉痉挛（作为休息和物理治疗的辅助药）。但环苯扎林对脑、脊髓疾病或儿童脑性瘫痪引起的痉挛无效。
Associated Conditions
- Muscle Spasms
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/15 | Phase 2 | Recruiting | |||
2023/01/13 | Phase 3 | Withdrawn | Eurofarma Laboratorios S.A. | ||
2022/07/25 | Phase 2 | Completed | |||
2022/05/13 | Phase 2 | Withdrawn | |||
2021/02/25 | N/A | Completed | |||
2020/08/11 | Phase 3 | Completed | |||
2020/05/29 | Phase 1 | Completed | |||
2020/01/27 | Phase 4 | Completed | |||
2019/11/21 | Phase 3 | Completed | |||
2019/11/15 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Asclemed USA, Inc. | 76420-271 | ORAL | 10 mg in 1 1 | 9/3/2022 | |
| Cephalon, LLC | 63459-701 | ORAL | 30 mg in 1 1 | 8/28/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-115 | ORAL | 5 mg in 1 1 | 9/25/2023 | |
| RxChange Co. | 33358-097 | ORAL | 10 mg in 1 1 | 11/6/2014 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-516 | ORAL | 10 mg in 1 1 | 9/26/2023 | |
| Proficient Rx LP | 63187-812 | ORAL | 10 mg in 1 1 | 4/1/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-2471 | ORAL | 7.5 mg in 1 1 | 3/11/2024 | |
| A-S Medication Solutions | 50090-1848 | ORAL | 7.5 mg in 1 1 | 2/18/2022 | |
| St Mary's Medical Park Pharmacy | 60760-536 | ORAL | 5 mg in 1 1 | 3/15/2023 | |
| Preferred Pharmaceuticals Inc. | 68788-8221 | ORAL | 5 mg in 1 1 | 5/3/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||