NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Feb 1962
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
Priority Review
QUINIDEX (quinidine sulfate) by Pfizer is (dm) is a sigma-1 receptor agonist and an uncompetitive nmda receptor antagonist. First approved in 1962.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QUINIDEX (quinidine sulfate) is an oral extended-release antiarrhythmic tablet approved in 1962 for treating pseudobulbar affect, a neurological condition characterized by uncontrolled emotional outbursts. The drug works as a sigma-1 receptor agonist and uncompetitive NMDA receptor antagonist, with quinidine acting as a CYP2D6 inhibitor to elevate dextromethorphan plasma levels.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30) suggests declining team resources and transition focus toward generic management or portfolio rationalization.
Mechanism of Action
(DM) is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist. Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for dextromethorphan. The mechanism by which dextromethorphan…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Started Oct 2017
601 enrolled
Agitation in Patients With Dementia of the Alzheimer's Type
Relative Bioavailability of Dabigatran Etexilate Capsules With and Without Quinidine Sulfate Tablets and to Measure the Effect of Quinidine on the Absorption of Fexofenadine in Healthy Male and Female Volunteers
Started Nov 2007
42 enrolled
Healthy
Career Relevance
Working on QUINIDEX offers limited career growth and stability given its LOE-approaching status and zero linked job openings. This product is best suited for professionals managing mature or declining portfolios or learning generic transition strategies in a low-pressure environment.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.