Pharmacokinetics of sublingual sufentanil tablets and efficacy and safety in the management of postoperative pain
Autor: | Neil Singla, Pamela P. Palmer, Stephen S. Hwang, Yu-Kun Chiang, Mark A. Evashenk, Lawrence Hamel, Harold S. Minkowitz |
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Rok vydání: | 2012 |
Předmět: |
Adult
Male Metabolic Clearance Rate Sufentanil medicine.medical_treatment Administration Sublingual Knee replacement Biological Availability Placebo Dosage form law.invention Young Adult Randomized controlled trial Pharmacokinetics law Abdomen Medicine Humans Least-Squares Analysis Arthroplasty Replacement Knee Infusions Intravenous Aged Pain Measurement Analysis of Variance Pain Postoperative business.industry General Medicine Middle Aged Arthroplasty Clinical trial Analgesics Opioid Anesthesiology and Pain Medicine Treatment Outcome Anesthesia Area Under Curve Female business medicine.drug Half-Life Tablets |
Zdroj: | Regional anesthesia and pain medicine. 38(2) |
ISSN: | 1532-8651 |
Popis: | A sublingual sufentanil tablet is being developed as a potential alternative to intravenous (IV) opioids for the management of postoperative pain. The objective of these studies was to evaluate the pharmacokinetics, efficacy, and safety of sublingual sufentanil tablets for postoperative pain management.The pharmacokinetics of sublingual sufentanil 10 and 80 µg were compared with IV sufentanil in 12 subjects in a phase 1 study. The safety and efficacy of sublingual sufentanil (5-15 µg) were evaluated in double-blind, randomized, placebo-controlled phase 2 studies in patients undergoing knee replacement surgery (n = 101) or open abdominal (ABD) surgery (n = 94). The primary efficacy measurement was the summed pain intensity difference compared with baseline over 12 hours (SPID-12).Sublingual sufentanil pharmacokinetics were dose proportional following single doses of 10 and 80 µg. Plasma half-time (time from peak plasma concentration to 50% of peak concentration) was 80 to 90 minutes for sublingual sufentanil compared with 15 minutes or less for IV sufentanil. In the phase 2 studies, greater SPID-12 scores (ie, lower pain intensity) compared with placebo were observed for sublingual sufentanil 15 µg in the knee replacement study (P0.05) and for 10 and 15 µg in the ABD study (P0.01). All doses of sublingual sufentanil were well tolerated, and the incidence of adverse events was similar between the sublingual sufentanil and placebo groups.Sufentanil formulated as a sublingual solid dosage form provides a duration of action that allows effective analgesia for postoperative patients in a medically supervised setting. |
Databáze: | OpenAIRE |
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