Phase II trial of NUVIGIL Tablets for treatment of schizophrenia fails to meet primary endpoint: Cephalon

Cephalon, Inc. (Nasdaq: CEPH) today announced that the primary endpoint was not met in a Phase II clinical trial that examined NUVIGIL® (armodafinil) Tablets [C-IV] as an adjunctive therapy for the treatment of the negative symptoms of schizophrenia, which include problems with motivation and emotional withdrawal. The analysis of the data showed that treatment with armodafinil did not lessen the severity of the negative symptoms of schizophrenia compared to placebo in the 24-week study.  As a result of the outcome of this trial, Cephalon has decided not to move forward with this clinical program.

The trial was designed to evaluate whether armodafinil treatment (150, 200, or 250 mg/day) was more effective than placebo treatment as an adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia, as assessed by the primary outcome measure of the Positive and Negative Syndrome Scale.  Although an interim analysis showed a trend towards a positive dose dependent treatment effect, it was not statistically significant and not maintained in the final analysis of all patients.  Armodafinil was generally well tolerated in the study and the side effects were consistent with the known safety profile.  Results of this study will be presented at a future medical meeting.

"While we are disappointed that the results of this study did not demonstrate a benefit for this patient population, Cephalon remains committed to the NUVIGIL clinical development plan," said Dr. Lesley Russell, Chief Medical Officer at Cephalon.  "We are continuing our discussions with the agency on our application for excessive sleepiness associated with jet lag disorder and Phase III trials are on track evaluating armodafinil in bipolar depression and excessive sleepiness resulting from traumatic brain injury."