Neos Therapeutics initiates, completes dosing in Phase 1 trial of NT0502
Neos Therapeutics announced that it has initiated and completed dosing in a Phase 1 pilot pharmacokinetic study evaluating the safety and tolerability of NT0502 in healthy volunteers. NT0502 is a new chemical entity and selective anticholinergic agent that, based on preclinical data, is preferential for blocking muscarinic receptors in the salivary glands. The Company is developing NT0502 for the treatment of chronic sialorrhea, which is defined as prevalent and excessive drooling from the mouth resulting from the inability to control and swallow oral secretions, a common problem in patients with a variety of debilitating neurological conditions. Top-line pharmacokinetic data from the study is expected in the first quarter of 2020. The Phase 1 trial for NT0502 is a single-dose open-label, randomized study to assess the systematic exposure and safety of four ion-resin, modified-release orally disintegrating tablet formulations of NT0502 and oxybutynin in 30 healthy adults. Data from this study will provide insights into the pharmacokinetic profile of the four formulations and provide guidance on final formulation selection and dosing for future clinical trials.