Grand Prairie, Texas-based Neos Therapeutics, Inc., a pharmaceutical firm developing a new approach to treatment of attention deficit hyperactivity disorder (ADHD), recently announced the resubmission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for its experimental therapy NT‐0202, which is an amphetamine XR orally disintegrating tablet (XR-ODT) product candidate for ADHD.
Neos Therapeutics was initially focused on developing one lead ADHD candidate, but has now advanced three branded product candidates that offer XR medications in friendlier dosage forms, which the company believes will help improve patient compliance and efficacy.
ADHD is one of the most frequent childhood disorders and it can extend through adulthood; symptoms include problems in remaining focused and paying attention (particularly in school settings), and include difficulty in controlling behavior and hyperactivity (know also as “over‐activity”).
The NDA resubmission of the product includes new information that directly answers questions and information requests in an FDA Letter received in 2013, including the outcomes of an additional pharmacokinetic study of NT-0202. In addition, this is a Class 2 resubmission for Neos which means that, if approved, NT-0202 will become the first amphetamine XR-ODT to address ADHD to be approved by the FDA. Similarly, Cotempla XR‐ODT™, Neos’ methylphenidate XR-ODT candidate, is now under FDA review as well and if approved will be the first methylphenidate XR‐ODT available on the market to address ADHD.
“Our product candidates incorporate two of the most commonly prescribed medications for the treatment of ADHD, methylphenidate and amphetamine. Our proprietary modified-release drug delivery technology platform has enabled us to combine two key drug delivery attributes in each of these product candidates: an extended-release profile, which allows for once daily dosing, and an ODT dosage form, which disintegrates in the mouth, without the need for water,” noted the President and CEO of Neos, Vipin K. Garg.
Through the use of stimulant drugs like methylphenidates and amphetamines, which are the standard care for ADHD, and thanks to XR formulations of these specific medications, it is possible to address treatment with once‐daily doses. Recent data suggests however that many people with ADHD have difficulty in swallowing these doses. ODTs are different from traditional tablets and capsules since they are designed to disintegrate on the tongue without water, which would improve compliance in the ADHD patient population.