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Study 2, a Phase 2a parallel group study (placebo, 1, 3, 10 and 20 mg NG2-73) in healthy adults (N=369, PK in 133 subjects), evaluated NG2-73 sleep onset (latency to persistent sleep, LPS) relative to placebo. NG2-73 Cmax related to half-maximal LPS decrease was less than Cmax observed from NG2-73 1 mg. DSST ER modeling consistently supported the less than 2 ng/mL target to minimize next morning effects.
ER models guided doses and formulations for ongoing Phase 2b patient studies, which aim to confirm these relationships in patients, and establish the concentrations necessary for sleep maintenance. Model-based development using ER will continue supporting informed NG2-73 clinical development decisions.
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, obesity, pain, Parkinson's disease, restless legs syndrome (RLS), and depression. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
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