clock is ticking, page-5

Off-label drug use (OLDU) may even be considered integral to public health. OLDU occurs in virtually every therapeutic area and is relatively common in pediatrics as well as elderly populations.

Once approved, it is generally accepted that physicians may prescribe drugs for any therapeutic use which is considered appropriate in their medical judgement. The use of OLDU may highlight conditions which warrant supplementary clinical trials.

CNS conditions represent a world of unmet need where one approved drug addressing the underlying critical pathology - safe and well tolerated - could become, well - aspirin for the brain.