NDAORALTABLET
Approved
Aug 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
ROXICODONE (oxycodone hydrochloride) by Bayer is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. First approved in 2000.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROXICODONE is an oral immediate-release tablet formulation of oxycodone hydrochloride, a full mu-opioid receptor agonist indicated for acute, chronic, and osteoarthritis pain management. It works by binding to opioid receptors in the brain and spinal cord to produce analgesia without a ceiling effect, though dosing is limited by adverse effects including respiratory and CNS depression.
LOE Approaching
As ROXICODONE approaches loss of exclusivity with competitive pressure at 30%, brand team size is likely contracting with focus shifting to generic transition or specialized pain management segments.
Mechanism of Action
mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. 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 (4)
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
Started Jun 2012
410 enrolled
Chronic PainLow Back PainAnalgesia
Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
Started Oct 2011
23 enrolled
Pain
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
Started Dec 2010
395 enrolled
Chronic Noncancer Pain
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Started Nov 2010
155 enrolled
Pain
Worked on ROXICODONE at Bayer? Share your interview experience or compensation data (+7 days Pro)
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.