Neos Therapeutics, a highly differentiated oral drug delivery company,
has completed a positive phase 3 study for its methylphenidate XR-ODT
drug candidate, NT-0102, in children with ADHD.
The trial was a multicentre, randomised, double-blind, placebo-controlled laboratory classroom study in 87 children with a diagnosis of ADHD. NT-0102 met primary and secondary efficacy endpoints, showing statistically significant improvement on both the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale, through 12 hours post-dose. No serious adverse events were reported during the study and the adverse event profile was consistent with the drug’s mechanism of action.
“ADHD is a condition that causes significant distress for patients and caregivers. Although, there are a number of effective long-acting medications currently on the market, most formulations consist of tablets or capsules that can be difficult for children to swallow. The positive data from this study is exciting. Hopefully, soon we will have a once-daily oral disintegrating tablet option that is easy to administer to patients,” said Dr. Ann Childress (Centre for Psychiatry and Behavioural Medicine, La Vegas, NV), lead investigator for the study
The trial was a multicentre, randomised, double-blind, placebo-controlled laboratory classroom study in 87 children with a diagnosis of ADHD. NT-0102 met primary and secondary efficacy endpoints, showing statistically significant improvement on both the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale, through 12 hours post-dose. No serious adverse events were reported during the study and the adverse event profile was consistent with the drug’s mechanism of action.
“ADHD is a condition that causes significant distress for patients and caregivers. Although, there are a number of effective long-acting medications currently on the market, most formulations consist of tablets or capsules that can be difficult for children to swallow. The positive data from this study is exciting. Hopefully, soon we will have a once-daily oral disintegrating tablet option that is easy to administer to patients,” said Dr. Ann Childress (Centre for Psychiatry and Behavioural Medicine, La Vegas, NV), lead investigator for the study
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