CLOBAZAM
Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Details
- Status
- Prescription
- First Approved
- 2018-10-22
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, TABLET
Companies
CLOBAZAM Approval History
What CLOBAZAM Treats
18 FDA approvalsOriginally approved for its first indication in 2018 . Covers 18 distinct patient populations.
- Other (18)
Other
(18 approvals)- • Approved indication (Oct 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Apr 2019)
- • Approved indication (May 2019)
- • Approved indication (Jul 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Oct 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Feb 2020)
- • Approved indication (Apr 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Dec 2020)
- • Approved indication (May 2021)
- • Approved indication (May 2021)
- • Approved indication (Mar 2022)
- • Approved indication (Sep 2022)
CLOBAZAM Boxed Warning
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [ see Warnings and Pre...
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [ see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )] . The use of benzodiazepines, including clobazam oral suspension, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing clobazam oral suspension and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions ( 5.2 )]. The continued use of benzodiazepines, including clobazam oral suspension, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of clobazam oral suspension after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clobazam oral suspension or reduce the dosage [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.3 )]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS ; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Res
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02565108 results posted | GWEP1428 Blinded Phase 2014-002942-33 | Ph 2 | completed | A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol |
| NCT02564952 results posted | GWEP1428 Open-Label Extension 2014-002942-33 | Ph 2 | completed | An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol |
| NCT03371836 results posted | onfi90037 | Ph 4 | completed | Use of Clobazam for Epilepsy and Anxiety |
| NCT02134366 | EPC-1 | Ph 3 | terminated | Clobazam Use in Epilepsia Partialis Continua - Pilot Study |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT02187809 results posted | 14362B | Ph 3 | terminated | Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome |
| NCT01179828 Predictio | KEK 213/09 grant: SPUM no. 33CM30_124117 | Ph 3 | completed | Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio) |
| NCT02174094 | 14362A | Ph 3 | withdrawn | Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome |
| NCT01291316 | GABA-SPUM | Ph 1, Ph 2 | completed | GABAergic Modulation in Pain Transmission in Human: Effect of the GABAA Agonist Clobazam on Peripheral and Central Sensitisation |
| NCT01011036 | 152/09 SNF SPUM no.33CM30_124117 | Ph 3 | completed | Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CLOBAZAM FDA Label Details
Indications & Usage
Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam oral suspension is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients...
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Full clinical data, patents, trials, and competitive landscape for clobazam.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.