HYDROCODONE BITARTRATE

Post-LOE

hydrocodone bitartrate

ANDAORALCAPSULE, EXTENDED RELEASE
Approved
Jan 2020
Lifecycle
Post-LOE
Competitive Pressure
45/100
Clinical Trials
15

Mechanism of Action

mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Clinically, dosage is titrated to provide adequate…

Clinical Trials (5)

NCT02487108Phase 3Completed

Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy

Started Aug 2015
569 enrolled
Pain
NCT01922739Phase 3Completed

Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets

Started Jul 2013
182 enrolled
Low Back Pain
NCT01789970Phase 3Completed

Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

Started Mar 2013
625 enrolled
Low Back Pain
NCT01769677Phase 1Completed

A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet

Started Jan 2013
54 enrolled
Pain
NCT01758978Phase 1Completed

A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet

Started Dec 2012
54 enrolled
Pain