(HealthNewsDigest.com) - Dallas/Fort Worth, TX (June 25, 2015) - Neos Therapeutics, Inc. ..Today announced the presentation of new data at the American Society of Clinical Psychopharmacology Annual Meeting ("ASCP") in Miami, Florida. The results from two clinical trials of the Company's methylphenidate XR orally disintegrating tablet ("ODT") drug candidate, Cotempla XR-ODTTM (formerly NT-0102), and one clinical trial of its amphetamine XR-ODT drug candidate, NT-0202, were presented. The data confirm that both formulations have a concentration-time profile that is consistent with once daily dosing, and that they maintain their extended-release properties in the presence of a high fat meal and varying concentrations of alcohol. Tolerability data was also presented.
"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," said Ann Childress M.D., University of Nevada School of Medicine and President, Center for Psychiatry and Behavioral Medicine, Las Vegas, Nevada. "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."
Up to 54% of pediatric patients and 40% of adult patients in the general population are reported to have difficulty swallowing tablets and capsules, which may result in skipped doses or discontinuance of their medication altogether. Cotempla XR-ODTTM and NT-0202 disintegrate in the mouth without water and provide a pharmacokinetic ("PK") profile that is consistent with once-daily dosing.
"We are pleased that the results of the studies presented at ASCP suggest that Cotempla XR-ODTTM can be dosed with or without food and has a similar pharmacokinetic profile to a marketed methylphenidate capsule product," said Vipin K. Garg, Ph.D., President and CEO of
Neos Therapeutics. "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."
In January 2015, Neos announced the submission of a New Drug Application ("NDA") for Cotempla XR-ODTTM to the U.S. Food and Drug Administration ("FDA"). The NDA was accepted for filing by the FDA on March 10, 2015, and has a Prescription Drug User Fee Act ("PDUFA") goal date of November 9, 2015. If approved, the Company believes Cotempla XR-ODTTM will be the first methylphenidate extended-release orally disintegrating tablet for the treatment of ADHD, potentially providing patients the combination of two key drug delivery attributes - an extended-release profile which allows for once-daily dosing and an ODT dosage form which disintegrates in the mouth without water - in one formulation.
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