NPL-2008 (Neuropharm)

NPL-2008 is a low-dose, orally disintegrating tablet (ODT) formulation of fluoxetine developed by Neuropharm Group Plc for the treatment of autistic disorder. As a selective serotonin reuptake inhibitor (SSRI), it was designed to address repetitive behaviors in children and adolescents (ages 5-17) by increasing synaptic serotonin levels. The formulation was specifically engineered as a 'melt-in-the-mouth' tablet to facilitate administration in a pediatric population with neurodevelopmental disorders. Clinical development included the Phase 2/3 SOFIA study and the open-label EMMA follow-on study. However, the SOFIA study failed to demonstrate a statistically significant reduction in repetitive behaviors compared to placebo, leading to the termination of the program.

Other names

fluoxetine ODTfluoxetine orally disintegrating tablet