Lynn R. Webster* and Perry G. Finey *Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah. y Pain Research Center, University of Utah School of Medicine, Salt Lake City, Utah.
ELI-216 Elite Pharmaceuticals is developing ELI-216, an extended-release formulation of oxycodone containing sequestered naltrexone. ELI-216 is similar in design to ALO-01 except that in ELI-216 capsules oxycodone and naltrexone are in separate pellets. Because the naltrex- one pellets are nonporous, naltrexone is not released when the capsule is ingested whole (intact); naltrexone is only released when the capsule or pellets are crushed. Elite has conducted a study that successfully demon- strated the euphoria-blocking effects of ELI-216: subjects (n = 17) dosed with crushed ELI-216 reported a much lower level of euphoria during the first 3 hours than those dosed with crushed oxycodone hydrochloride extended-release capsules (average peak euphoria: <10 vs 71 [0–100-mm scale], respectively).9 Elite Pharmaceuti- cals is currently conducting a phase-3 study to evaluate the safety and efficacy of ELI-216 in patients with osteoarthritis.
A Pilot Study To Select A Dose of Naltrexone Hydrochloride That Will Reduce Subjective Euphoric Effects Of Oxycodone Hydrochloride in Non-Dependent, Opioid-Preferring Subjects
Lynn R. Webster, MD1, Robert A. Medve, MD1, Bernard J. Berk, BS2, Chris C. Dick, BS, MS, MBA2, and Charan R. Behl, PhD2. (1) Lifetree Clinical Research, Salt Lake City, UT, USA, (2) Elite Pharmaceuticals, Northvale, NJ, USA Objective:
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