QUINIDEX

LOE Approaching

quinidine sulfate

NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Feb 1962
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2

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…

Clinical Trials (2)

NCT03393520Phase 3Completed

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
NCT02171546Phase 1Terminated

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