An Autism-Friendly Formulation

AT001 has been formulated in an autism-friendly formulation using Catalent Pharma Solutions’ ZYDISTM technology. It consists of a taste masked rapidly orally disintegrating tablet (ODT) containing fluoxetine bound to an ion exchange resin, preventing the release of fluoxetine, which has a bitter taste when unbound, until it reaches the stomach where the higher acidity (stomach pH = 2 vs. pH=7 in the mouth) releases the drug. The tablet rapidly dissolves on contact with the saliva. Two successful bioequivalence studies have been conducted to demonstrate the formulation’s bioequivalence to liquid fluoxetine.

There are a number of advantages inherent to rapidly dissolving orally disintegrating tablet in pediatric and autistic populations. The literature demonstrates that compliance is compromised in patients with Autistic Disorder. There are issues with swallowing medication in this patient group of children and adolescents, some of whom will be intellectually handicapped and have sensory-processing problems. The orally disintegrating tablet is ideal because it has a pleasant mouth feel. Also, it dissolves rapidly, cannot be easily spit out and is easily swallowed. Finally, the taste is pleasant (cherry) and not bitter due to binding of the drug to the ion exchange resin.

AT001 Available in Ultra-low Dose

AT001 is being manufactured in multiple dose strengths, as low as 2mg, to allow physicians the ability to slowly titrate up the dose in order to identify the ideal dose for clinical efficacy.