Nuvigil armodafinil regulatory update

FDA issued a complete response letter for an sNDA from Cephalon for Nuvigil armodafinil to treat excessive sleepiness associated with jet lag disorder from eastbound travel. The company said the letter raised questions regarding the "robustness" of data on the co-primary endpoint of improving Patient Global Impression of Severity (PGI-S) vs. placebo, despite achieving statistical significance on the endpoint. The company, which has an SPA from FDA for the Phase III trial, said it plans to meet with the agency to discuss the issue. ...