Comparative Pharmacology
Head-to-head clinical analysis: ROXICODONE versus SUBSYS.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ROXICODONE versus SUBSYS.
ROXICODONE vs SUBSYS
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Oxycodone is a full opioid agonist with high affinity for mu-opioid receptors, also binding to kappa and delta receptors. It acts primarily on the central nervous system and gastrointestinal tract.
SUBSYS (fentanyl) is a mu-opioid receptor agonist that produces analgesia by mimicking endogenous opioids, increasing potassium efflux and reducing calcium influx, thereby inhibiting neuronal transmission of pain signals.
5-15 mg orally every 4-6 hours as needed for pain; immediate-release formulation. Maximum 60 mg total daily dose for opioid-naive patients.
SUBSYS (fentanyl buccal soluble film) is indicated for breakthrough pain in opioid-tolerant patients. Initial dose: 100 mcg (one 100 mcg film) placed on the inner cheek, allowed to dissolve over 15-25 minutes; may repeat once after 30 minutes if pain not relieved. Titrate to effective dose (200, 400, 600, 800, 1200, 1600 mcg). Maximum: 4 doses per day. No more than 2 doses per breakthrough pain episode. Wait at least 2 hours before treating next episode.
None Documented
None Documented
3.5-5 hours for immediate-release; 4.5-5.5 hours for extended-release. Accumulation may occur with repeated dosing, especially in elderly or hepatic impairment.
Terminal half-life 2–4 hours (single dose); prolonged to 7–15 hours in hepatic/renal impairment; clinical context: necessitates q4–6h dosing for chronic pain.
Renal excretion: 70-80% as unchanged drug and metabolites (oxymorphone, noroxycodone); fecal: 10-20%.
Primarily renal (~75% as metabolites, <10% unchanged); biliary/fecal excretion of conjugates; ~9% in feces.
Category C
Category C
Opioid Analgesic
Opioid Analgesic