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ACOMPLIA (RIMONABANT): PRECLINICAL SAFETY DATA
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Convulsions were observed sporadically in studies in rodents and macaques. No convulsions were observed in dogs during a 3 month study. In some, but not all cases, initiation of convulsions appeared to be associated with procedural stress such as handling of the animals. A proconvulsant activity of rimonabant was found in one of two safety pharmacology studies. No adverse effect of rimonabant treatment was observed on EEG patterns in rats.
Increased incidence and/or severity of clinical signs suggestive of increased tactile hyperesthesia were observed in rodent studies. A direct effect of rimonabant cannot be ruled out.
Liver steatosis and a dose-related increase in centrilobular necrosis were observed in long-term studies in the rat. A direct effect of rimonabant cannot be ruled out.
In standard fertility studies in female rats (dosing for 2 weeks prior to mating) there was abnormal oestrous cyclicity and a decrease in corpora lutea and fertility index at doses of rimonabant that induced maternal toxicity (30 and 60 mg/kg/day). Following dosing for a longer treatment duration prior to mating (9 weeks) that permitted recovery from the initial effects of rimonabant, no adverse effects were seen on fertility or oestrous cyclicity. Regarding reproductive parameters, at 30 mg/kg no differences were observed between treated animals and controls, at 60 mg/kg effects were still observed (decreased number of corpora lutea, implantations, total and viable fetuses).
Sporadic malformations (anencephaly, micro-ophthalmia, widened brain ventricles and omphalocele) were observed in the rabbit embryofetal toxicity studies at doses resulting in exposures comparable with the clinical exposures. Although maternal toxicity was observed at these doses, a relation to treatment cannot be excluded. No treatment-related malformations were seen in the rat.
Effects of rimonabant on pre-and post-natal development were assessed in the rat at doses up to 10 mg/kg/day. There was a treatment related increase in pup mortality in the pre-weaning period. The increased pup mortality might be attributable to a failure of the dam to nurse or ingestion of Acomplia (Rimonabant) in milk and/or inhibition of the suckli
ng reflex that is reported in the literature to be initiated in neonatal mice by endocannabinoid signalling via CB1 receptors. There are reports in the literature that, in both rodents and humans, the spatial distribution and density of CB1 receptors in the brain changes during development. The potential relevance of this to administration of a CB1 antagonist is unknown. In the pre- and post-natal development study in rats, exposure to rimonabant in utero and via lactation produced no alterations on learning or memory, but equivocal effects on motor activity and auditory startle response were observed in the pups as a result of Rimonabant (Acomplia) exposure.
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