US FDA calls for more data on Cephalon's Nuvigil for jet lag sleepiness, as firm receives setback in pay-for-delay deal on Provigil

US drugmaker Cephalon has received a Complete Response letter from the Food and Drug Administration for its supplemental new drug application for Nuvigil (armodafinil) in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel, raising questions about "the robustness" of data in a study of the drug regarding a subjective assessment called the Patient Global Impression of Severity.

Cephalon shares fell almost 5% to $69 in extended trading from their Nasdaq close at $72.62. Nuvigil sales in 2009 were $73.4 million, all of which were in the USA. The drug was introduced in the USA last June for excessive fatigue caused by narcolepsy, shift work and sleep apnea. Nuvigil is a longer-acting version of Provigil (modafinil), Cephalon's biggest-selling product, with sales last year of $1.02 billion. Approval of Nuvigil for jet lag could add as much as $150 million to the company's annual turnover, according to Oppenheimer & Co analyst Bret Holley.

Supporting clinical data