EXALGO

LOE Approaching

hydromorphone hydrochloride

NDAORALTABLET, EXTENDED RELEASE
Approved
Mar 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4

Mechanism of Action

Hydromorphone, a semi-synthetic morphine derivative, is a hydrogenated ketone of morphine. Hydromorphone is principally an agonist of mu-receptors, showing a weak affinity for k-receptors. Comparing relative binding affinity for mu- and k-opioid receptors, hydromorphone binds more specifically to…

Indications (2)

moderate to severe pain in opioid tolerant patients requiring continuousaround-the-clock opioid analgesia for an extended period of time ()

Clinical Trials (4)

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
NCT00980798Phase 3Completed

Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee

Started Oct 2007
288 enrolled
PainOsteoarthritis, HipOsteoarthritis, Knee
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers