Summary
NUVIGIL, Cephalon's single isomer longer effective half-life follow-up product to Provigil is coming to market only after careful strategic planning. While extremely successful, Provigil, a unique wake promoting agent, suffered in many ways. When introduced, it had only FDA approval for narcolepsy, a relatively uncommon, yet severe sleep disorder. Sales increased markedly when Provigil became approved for other common conditions associated with excessive daytime sleepiness (EDS), treated obstructive sleep apnea with residual EDS and sleep wake shift disturbance (SWSD). If approved for Jet Lag, there is the promise that Nuvigil will become available for an increasing enlarging marketplace.
Analysis
Much of Provigil's sales were for unlabeled indications, particularly prior to the above label change. Once the label was changed, physicians noted numerous additional applications including jet lag, treatment resistant depression, fatigue associated with medication use (e.g. narcotics) or illness (e.g. cancer, HIV, multiple sclerosis, Parkinson's and Alzheimer's Disease). Once Provigil became more widely used, particularly by primary care and psychiatry, given the relatively high cost of Provigil, insurance companies were understandably reluctant to approve Provigil for off-label indications.
