HYDROMORPHONE HYDROCHLORIDE

Post-LOE

hydromorphone hydrochloride

Hikma

ANDAORALSOLUTION

Approved

Jul 1998

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

HYDROMORPHONE HYDROCHLORIDE (hydromorphone hydrochloride) by Hikma is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. Approved for pain severe enough to require an opioid analgesic, for which alternative treatments are inadequate. First approved in 1998.

Drug data last refreshed 20h ago

Mechanism of Action

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

Indications (2)

pain severe enough to require an opioid analgesic for which alternative treatments are inadequate

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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 (7)

NCT01709747Phase 3Completed

Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration

Started Jun 2013

364 enrolled

Chronic Pain

NCT01709721Phase 3Completed

Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration

Started Feb 2013

153 enrolled

Management of Chronic Pain

NCT01205126Phase 3Completed

An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain

Started Dec 2009

260 enrolled

Pain

NCT00803283Phase 3Terminated

A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain

Started Nov 2008

2 enrolled

Cancer Pain

NCT01006356Phase 4Completed

An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer

Started Oct 2008

141 enrolled

CancerPain