The FDA has issued a complete response letter for Cephalon's Nuvigil application. The drugmaker was looking to expand the Provigil follow-up drug's label to include an indication for jet lag. Although the drug met its endpoints in the trial, the agency questioned the quality of the data Cephalon presented to support expanded approval of the drug.
"Although we reached statistical significance on both primary endpoints, the Complete Response letter raised questions regarding the robustness of the PGI-S data," said Dr. Lesley Russell, Cephalon's CMO. "We have already reviewed this issue with the FDA and will be scheduling a meeting with the Agency in the near future to discuss it further.
Nuvigil was approved last year for narcolepsy, shift work and sleep apnea. An approval for jet lag could have added an additional $150 million in annual sales. Oppenheimer analyst Bret Holley says that the delay could stretch from six to 18 months. Cephalon's shares dipped on the news.
- here's Cephalon's press release
- and here's the report