About AT001

AT001 (ZYDISTM Fluoxetine) is a taste masked, rapidly orally disintegrating tablet, in three unique dose strengths, of the selective serotonin reuptake inhibitor (SSRI), fluoxetine. The pharmacologic actions of fluoxetine (Lilly 110140) as an antidepressant based on inhibiting serotonin reuptake in the central nervous system are well-established from numerous preclinical studies (Wong et al., 1995) and from clinical investigations in children and adults (NDA 18-936; Vasa et al., 2006). In vitro and in vivo preclinical investigations have shown fluoxetine (and norfluoxetine, its major metabolite) to be potent and selective inhibitors of neuronal pre-synaptic reuptake of serotonin (NDA 18-936). In vivo studies have demonstrated that fluoxetine can restore acquisition of passive avoidance tasks in olfactory bulbectomized rats, enhance 5-HT-induced head twitch in mice, enhance 5-HT-induced depression of operant behavior in pigeons, and enhance the behavioral effects of 5-HT in rats working on a milk reinforcement schedule (NDA 18-936). Fluoxetine has also been shown to reverse social interaction problems in a mouse model of autism (Chadman, 2011).

Eleven clinical trials on the effect of fluoxetine in autism spectrum disorders (seven open label studies and four placebo controlled studies), in children and adolescents, adults, or mixed populations, have been conducted.