Lundbeck and Otsuka announced that the Food and Drug Administration (FDA) has granted Fast Track designation to idalopirdine for the treatment of mild to moderate Alzheimer’s disease.
Idalopirdine demonstrated positive study results in a Phase 2 trial as adjunctive therapy in moderate Alzheimer’s disease. The Companies are currently investigating idalopirdine as adjunct to acetylcholinesterase inhibitors in a large Phase 3 study to confirm the earlier trial findings. Additional Phase 3 studies are underway to evaluate idalopirdine as an adjunctive symptomatic therapy for patients with mild to moderate Alzheimer’s disease.
Idalopirdine is a selective 5HT6 receptor antagonist believed to modulate the balance between the excitatory glutamatergic neurons and the inhibitory GABAergic interneurons. When used as an adjunct to donepezil, idalopirdine potentiates the effects of the AChEI on ACh levels and on neuronal activity in the cortex and hippocampus.