Texas-based Neos Therapeutics, Inc., a pharmaceutical firm with 3 late-stage innovative, extended-release (XR) product candidates to address attention deficit hyperactivity disorder (ADHD), recently presented at the American Society of Clinical Psychopharmacology’s Annual Meeting (ASCP) in Miami, Florida. Data from 2 clinical trials on Cotempla XR-ODT™ (formerly NT-0102), a methylphenidate XR orally-disintegrating tablet (ODT) drug candidate, along with the company’s amphetamine XR-ODT drug candidate, were presented confirming that both substances have a concentration-time profile for a daily dose that maintains its properties even in the presence of high fat meals and alcohol.
“These studies offer valuable insights into Neos’ two extended-release orally disintegrating tablet drug candidates for ADHD, and demonstrate a pharmacokinetic profile similar to a marketed capsule product. The breadth of XR-ODT candidate data presented at ASCP reinforce that these formulations appear to provide a pharmacokinetic profile consistent with once daily dosing, maintain their extended-release properties in the presence of a high-fat meal and alcohol and are generally well-tolerated,” noted Ann Childress from the University of Nevada School of Medicine.
About 54 percent of pediatric patients and 40 percent of adult patients in the general population have trouble swallowing capsules and tablets, which might result in skipping doses or in patients discontinuing treatment. Both Cotempla XR-ODT™ and NT-0202 disintegrate in the mouth and there is no need for water and only needs to be taken once per day.
“We are pleased that the results of the studies presented at ASCP suggest that Cotempla XR-ODT™ can be dosed with or without food and has a similar pharmacokinetic profile to a marketed methylphenidate capsule product. We are also encouraged to see that the modified-release properties of NT-0202 are maintained in the presence of alcohol. We believe that this is the first public presentation of data from a study on the effects of alcohol on the PK parameters of an extended-release amphetamine formulation,” said Vipin K. Garg, Neos Therapeutics’ president.
Neos announced submitted a New Drug Application (NDA) for Cotempla to the FDA and if approved, this will be the first methylphenidate extended-release orally disintegrating tablet to address ADHD.
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