NDAORALTABLETPriority Review
Approved
Apr 2017
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
4
Data completeness
5/8 — Partial
Priority Review
ROXYBOND (oxycodone hydrochloride) by Bayer is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. First approved in 2017.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROXYBOND is an oral immediate-release oxycodone hydrochloride tablet formulation approved by FDA in 2017 for pain management. It works as a mu-opioid receptor agonist that provides analgesia with no ceiling effect, though precise mechanism remains incompletely understood. The drug is indicated for patients requiring opioid analgesics for moderate to severe pain.
$0.771MPart D
LOE Approaching2.1 years to LOEProduct approaching loss of exclusivity with modest Part D utilization; team size likely constrained as patent expiry nears.
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
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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.