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Nuedexta (20/10)
Nuedexta combines dextromethorphan (a sigma-1 receptor agonist) and quinidine (a CYP2D6 inhibitor) to reduce involuntary emotional expression disorder (pseudobulbar affect) by modulating emotional pathways in the brain.
Nuedexta combines dextromethorphan (a sigma-1 receptor agonist) and quinidine (a CYP2D6 inhibitor) to reduce involuntary emotional expression disorder (pseudobulbar affect) by modulating emotional regulation pathways in the brain. Used for Pseudobulbar affect (involuntary emotional expression disorder).
At a glance
| Generic name | Nuedexta (20/10) |
|---|---|
| Also known as | Dextromethorphan/Quinidine |
| Sponsor | St. Joseph's Hospital and Medical Center, Phoenix |
| Drug class | Sigma-1 receptor agonist combination |
| Target | Sigma-1 receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | FDA-approved |
Mechanism of action
Dextromethorphan acts as a sigma-1 receptor agonist, which modulates glutamatergic and monoaminergic neurotransmission involved in emotional regulation. Quinidine is added as a CYP2D6 inhibitor to increase dextromethorphan bioavailability and maintain therapeutic levels. Together, these components suppress the involuntary laughing or crying episodes characteristic of pseudobulbar affect.
Approved indications
- Pseudobulbar affect (involuntary emotional expression disorder)
Common side effects
- Dizziness
- Headache
- Nausea
- Asthenia/fatigue
- Vomiting
- Syncope
Key clinical trials
- Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease (PHASE2)
- Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis (PHASE2)
- Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease (PHASE4)
- Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine (PHASE2)
- Study to Assess the Bioavailability, Pharmacokinetics, Safety, and Tolerability of AVP-923 in Healthy Adult Participants (PHASE1)
- Nuedexta for the Treatment of Adults With Autism (PHASE2)
- Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA) (PHASE4)
- Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS (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:
- Nuedexta (20/10) CI brief — competitive landscape report
- Nuedexta (20/10) updates RSS · CI watch RSS
- St. Joseph's Hospital and Medical Center, Phoenix portfolio CI