DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (dextromethorphan hydrobromide) · PAR PHARM
This combination medication treats pseudobulbar affect (PBA), a condition where patients experience sudden and frequent episodes of involuntary laughing or crying. These episodes are often disconnected from the person's actual emotional state and occur alongside various neurological diseases or injuries. It helps patients manage these outbursts, which are distinct from other types of emotional changes seen in neurological conditions.
How DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Works
This drug works by combining dextromethorphan, which acts as a sigma-1 receptor agonist and NMDA receptor antagonist, with quinidine. Quinidine blocks the enzyme that normally breaks down dextromethorphan, which increases the amount of the drug available in the body. While the exact way these actions stop PBA episodes is not yet known, the combination ensures dextromethorphan reaches therapeutic levels.
Details
- Status
- None (Tentative Approval)
- First Approved
- 2017-10-10
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Approval History
What DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Treats
1 indicationsDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pseudobulbar Affect
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02651116 CHPA DXM results posted | A6531002 CHPA DXM | Ph 4 | terminated | Dextromethorphan Pediatric Acute Cough Study |
| NCT03480009 DexMab results posted | STUDY19020221 | Ph 3 | completed | Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion |
| NCT01441102 MiDME2 results posted | 110244 11-EI-0244 | Ph 1, Ph 2 | completed | Dextromethorphan for Diabetic Macular Edema |
| NCT02860962 | Pro00052508 | Ph 1 | completed | A Trial of Dextromethorphan for Treatment of Major Depressive Disorder |
| NCT01218620 | NCI-2012-02916 NCI-2012-02916, CDR0000685426 | Ph 1 | completed | Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors |
| NCT02182336 | 1220.32 | Ph 1 | completed | Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers |
| NCT01017939 | CR017128 COU-AA-015 | Ph 1 | completed | A Drug-Drug Interaction Study of Abiraterone Acetate Plus Prednisone With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer |
| NCT01441986 DXM/AMT | 0533-DXM | Ph 2 | completed | Dextromethorphan, Amantadine and Glucose Homeostasis in Diabetes Subjects |
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.
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE FDA Label Details
Indications & Usage
Dextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury. Dextromethorphan hydrobromide and quinidine sulfate capsules are ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.