Back in December drug maker Cephalon was anxiously awaiting an expected approval from the Food and Drug Administration (FDA) to permit their drug Nuvigil to be prescribed to treat jetlag associated with east-bound travel. They were thwarted then, with the FDA choosing to delay a ruling by three months. Well, the new deadline came and went and the FDA still has not issued a final ruling on the drug. Even more concerning for the manufacturer is that such an approval still seems a bit of a ways off.
The FDA most recently issued a complete response letter indicating that the the new indication would not be approved at this time. The basis for the delay is that the FDA is not quite sure that the results of the trial as “robust” enough statistically to show a true benefit versus a placebo. The good news is that the Agency didn’t outright deny the application. The decision to offer the letter instead permits the company and the Agency to discuss further before a final ruling is issued.
I’m actually not all that surprised by this move from the FDA. I’d tend to agree that the questionnaires used in the trial were, well, lacking in many ways. But I didn’t design the study and I’m not experienced in clinical drug trials so what do I know.
No word yet on an expected date for any future announcements on the trial.
- More on the “jetlag drug”
- A prescription cure for jetlag?
- Getting paid to fly, part 2
- France surrenders. Again.
- A quick jetlag recovery trick
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