VALTOCO (diazepam)
VALTOCO is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients with epilepsy. This therapy is intended for use when patients experience seizure clusters or acute repetitive seizures that are distinct from their usual seizure patterns. It is approved for use in both adult and pediatric populations aged 2 years and older.
How VALTOCO Works
While the exact mechanism of action for diazepam is not fully understood, it is thought to involve the enhancement of specific neurotransmitter activity. The drug binds to the benzodiazepine site of the GABA A receptor within the central nervous system. This binding results in the potentiation of GABAergic neurotransmission, which produces the medication's therapeutic effects.
Details
- Status
- Prescription
- First Approved
- 2020-01-10
- Patent Cliff
- 2042
- Routes
- NASAL
- Dosage Forms
- SPRAY
VALTOCO Approval History
What VALTOCO Treats
2 indicationsVALTOCO is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Epilepsy
- Seizures
VALTOCO 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 Prec...
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) and Drug Interactions (7.1) ] . The use of benzodiazepines, including VALTOCO, 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 VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2) ]. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use [see Indications and Usage (1) and Dosage and Administration (2) ] , if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO [see 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, respi
VALTOCO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VALTOCO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03818932 results posted | 123192 | Ph 2, Ph 3 | completed | Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction |
| NCT07020988 | UP0127 | Ph 1 | completed | A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants |
| NCT05361447 | 21-007195 | Ph 1, Ph 2 | withdrawn | Diazepam Trial in GAD65 Associated Epilepsy |
| NCT06103188 results posted | M001 | Ph 3 | completed | Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively |
| NCT01938092 results posted | 1208827 | Ph 2 | completed | Vaginal Diazepam for the Treatment of Female Pelvic Pain |
| NCT03818919 results posted | 123191 | Ph 2 | completed | Nonopioid Analgesia After Rotator Cuff Repair |
| NCT02904265 results posted | 16-002442 | Ph 2, Ph 3 | terminated | Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome |
| NCT01364558 results posted | 1012M93599 | Ph 1 | completed | A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers |
| NCT02494180 results posted | KW/FR-15-021(83-22) | Ph 4 | completed | A Non-inferiority Trial on Pain Relief During Oocyte Retrieval |
| NCT03825809 | 1231914 | Ph 2, Ph 3 | recruiting | Nonopioid Analgesia After Labral Surgery |
| NCT02646124 results posted | 2015-4639 | Ph 2, Ph 3 | completed | Diazepam Use With Standard Management for Acute Low Back Pain |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01417078 results posted | DZNS-ARS-103 | Ph 2 | completed | A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode |
| NCT02935972 | Diazepam and TRUS Biopsy | Ph 2, Ph 3 | completed | Combined Intravenous Diazepam, Local Periprostatic Nerve Block for Prostate Biopsy |
| NCT01438749 | BP25259 | Ph 1 | completed | A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users |
| NCT01675648 | Lofex00428 | Ph 4 | completed | Lofexidine for Inpatient Opiate Detox in Singapore |
| NCT01939093 MAP | NRCT-53069 | Ph 4 | completed | Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis |
| NCT01318369 Delta-pain | HEEL-2011-01 | Ph 2 | completed | Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain |
Active Pipeline
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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.
VALTOCO FDA Label Details
Indications & Usage
FDA Label (PDF)VALTOCO is indicated for the treatment of Epilepsy; Seizures.
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...
VALTOCO Patents & Exclusivity
Patents (8 active)
Exclusivity
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 72 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.