FENTANYL CITRATE

Post-LOE

fentanyl citrate

Hikma

ANDATRANSMUCOSALTROCHE/LOZENGE

Approved

Oct 2009

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

FENTANYL CITRATE (fentanyl citrate) by Hikma is analgesia. Approved for breakthrough pain in cancer patients 16 years of age, older, migraine. First approved in 2009.

Drug data last refreshed 19h ago

Mechanism of Action

analgesia.

Indications (3)

breakthrough pain in cancer patients 16 years of age older migraine

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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.

Clinical Trials (3)

NCT00343733Phase 3Completed

Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain

Started Aug 2006

120 enrolled

Pain

NCT00214942Phase 3Completed

Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain

Started Sep 2005

Chronic Low Back Pain

NCT00214955Phase 3Completed

Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain

Started Sep 2005

120 enrolled

Chronic Neuropathic Pain