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| |  Antiepileptic Agent Carisbamate Does Not Interact With Ethanol: Presented at AACP By Maggie Schwarz PHILADELPHIA -- September 17, 2008 -- Adverse events are more frequent with ethanol alone than with ethanol plus carisbamate, according to results of a drug-drug interaction study presented here at the American College of Clinical Pharmacology (ACCP) 37th Annual Meeting. Martha D. Gonzalez, BS, Pharmacodynamic/Pharmacokinetic Scientist, Johnson and Johnson Pharmaceutical Research and Development, Titusville, New Jersey, reported on the study results in a presentation on September 15. Carisbamate is a new chemical entity with anticonvulsant activity that is under investigation for adjunctive treatment of epilepsy and neuropathic pain. Comprehensive receptor binding and functional assays have not identified a mode of action for carisbamate that fully explains its broad spectrum of activity in animal seizure models, Gonzalez said. Thirty-four healthy moderate alcohol drinkers received oral carisbamate 200 mg or placebo twice daily over 8 days during period 1 or 2. On day 7 of each period, subjects received a placebo beverage. On day 8 of each period, subjects received an oral ethanol (vodka) dose approximating the amount patients would ingest if they were to drink socially. Ethanol amounts tested were a little higher than that, and dosed by weight. On days 7 and 8 of each period, serial blood samples were collected for pharmacokinetic analysis of carisbamate and ethanol and serial pharmacodynamic assessments of cognitive and psychomotor functions were performed. Pharmacodynamic tests consisted of 5 psychomotor and cognitive tests, namely stabilometric platform, choice reaction time, divided attention, Sternberg short memory task, and digit vigilance test. In addition, visual analogue scale tests, dizziness, fatigue, nausea, and sedation were administered as subjective measures used to assess subjects' perception of carisbamate and ethanol given alone or in combination. The researchers enrolled 17 men and 17 women; 16 were white, 11 Black, 5 Asian, and 2 were listed as "other". Subjects were a median of 34 years old and had a mean body mass index of 25.5. In most cognitive tests, a high degree of overlap was observed between scores for carisbamate alone and placebo alone. An influence of carisbamate could not be detected for most of the tests. Twice-daily carisbamate had no discernible effect on the perception of alertness, bad effects, dizziness, nausea, or sedation relative to placebo. Carisbamate had no discernible impact on subjective assessments relative to placebo. Overall adverse effects were nominally more frequent after administration of ethanol alone compared with ethanol plus carisbamate. Gonzalez concluded that carisbamate does not alter the pharmacokinetics of ethanol, nor does ethanol alter the pharmacokinetics of carisbamate. "Carisbamate did not potentiate ethanol-related impairment of cognitive or psychomotor function," she stated. "Carisbamate given alone or with ethanol was well tolerated and was not associated with any unexpected adverse effects." [Presentation title: A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Drug-Drug Interaction Study Between Carisbamate and Ethanol in Healthy Subjects. Abstract 129]
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