NDAORALTABLET, EXTENDED RELEASE
Approved
Mar 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
EXALGO (hydromorphone hydrochloride) by Pfizer is hydromorphone, a semi-synthetic morphine derivative, is a hydrogenated ketone of morphine. First approved in 2010.
Drug data last refreshed 8h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXALGO is an extended-release oral tablet formulation of hydromorphone hydrochloride, a potent semi-synthetic opioid agonist approved in 2010. It is indicated for moderate-to-severe chronic pain management in opioid-tolerant patients. Hydromorphone works primarily through mu-opioid receptor agonism in the central nervous system, with analgesic efficacy limited clinically by adverse effects including respiratory depression, sedation, nausea, and vomiting.
LOE Approaching
Product is nearing loss of exclusivity with moderate competitive pressure (30/100), indicating downsizing commercial operations and transition planning for generic environment.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration
Started Jun 2013
364 enrolled
Chronic Pain
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
Started Feb 2013
153 enrolled
Management of Chronic Pain
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
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
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
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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.