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R John Stubbs

Stubbs & Hensel Pharma Consulting, LLC, PO Box 935, Blue Bell, PA 19422, USA.

1 paper in the library · 10 citations · publishing 2016

Papers

Functional neurotoxicity evaluation of noribogaine using video-EEG in cynomolgus monkeys.

Journal of pharmacological and toxicological methods January 1, 2016 Simon Authier, Michael V Accardi, Dominique Paquette et al. 10 citations

In cynomolgus monkeys, noribogaine—a drug being developed for opioid dependence—did not cause seizures or EEG signals that warn of increased seizure risk, even at the highest dose tested (320 mg/kg). Monkeys showed mild behavioral effects such as reduced activity, scratching, licking, chewing, and some poor coordination. One monkey had brief myoclonic movements at the high dose, but these did not spread or link to EEG abnormalities. In contrast, the positive control pentylenetetrazol consistently triggered seizure-related EEG patterns and generalized seizures. The study establishes 320 mg/kg as the EEG no observed adverse effect level for noribogaine in this model.