Cephalon, Inc. (CEPH)

[surf1944]

4:48PM Cephalon receives complete response letter for NUVIGIL for the treatment of excessive sleepiness associated with jet lag disorder (CEPH) 71.75 +1.16 : Co announced that it has received a Complete Response letter from the FDA for its supplemental new drug application for NUVIGIL (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Patients taking NUVIGIL (150 mg/day) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p=0.044]. The most common adverse events associated with NUVIGIL treatment (five percent or greater) were headache, nausea, insomnia, diarrhea and palpitations. There were no reports of serious rash observed in the trial participants, and no new safety signals were observed in the clinical trial.