NDAORALCAPSULE, EXTENDED RELEASE
Approved
Sep 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
PALLADONE (hydromorphone hydrochloride) by Purdue Pharma is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. First approved in 2004.
Drug data last refreshed 14h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PALLADONE (hydromorphone hydrochloride) is an extended-release oral opioid agonist approved in 2004 for moderate-to-severe pain management. It binds to mu-opioid receptors in the CNS to produce analgesia without a ceiling effect, with dosing titrated to patient response and tolerability.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting transition planning and team restructuring may be underway.
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
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.