Cephalon reports positive results from Phase III jet lag sleepiness study

Cephalon, a biopharmaceutical company, has reported positive results from a Phase III clinical trial of Nuvigil tablets as a treatment for excessive sleepiness associated with jet lag disorder.

The efficacy and safety of Nuvigil as a potential treatment for acute excessive sleepiness associated with jet lag disorder were evaluated over the course of three days in a randomized, double-blind, placebo-controlled study of 427 healthy adults who had experienced jet lag symptoms during the previous five years.

Participants in the study traveled eastbound from the US to France where they were then examined at a sleep facility. Clinical efficacy was evaluated using two primary endpoints: an objective assessment – the multiple sleep latency test (MSLT), and a subjective assessment – the patient global impression of severity (PGI-S). Patients taking Nuvigil (150mg) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05]. Nuvigil was generally well-tolerated in the study.

Based on these findings, Cephalon will file a supplemental new drug application with the FDA to expand the indications for Nuvigil during the third quarter of 2009. Cephalon is preparing to launch Nuvigil, the longer-lasting isomer of modafinil, in the third quarter of 2009.

Lesley Russell, chief medical officer of Cephalon, said: After flying the subjects over the Atlantic, we objectively evaluated those receiving placebo versus those receiving Nuvigil. We discovered that those on placebo were as excessively sleepy as narcoleptics and that the treatment effect for those on Nuvigil was the largest we have seen to date. We are pleased that this positive study will allow us to file our first supplemental new drug application for an acute use of Nuvigil.