Cephalon aims Nuvigil at depression

Cephalon won't let Provigil go gently into that post-patent night. Already, the drugmaker has readied its follow-up: Nuvigil, an extended release form of the stay-awake drug. Like Effexor and Effexor XR before it (and Wellbutrin and Wellbutrin SR and Wellbutrin XL, and any number of other follow-up twin/triplets), Nuvigil is designed to capture market share from Provigil with its simpler dosing regimen.

And Nuvigil is like those antidepressants in another respect: Cephalon is testing it as--yes--an antidepressant. And today, Cephalon announced some favorable data from a Phase II trial: As an add on to mood-stabilizers for major depression in adults with bipolar disorder, Nuvigil improved depressive symptoms as measured by a common inventory. "We are encouraged that the results of this study point toward the potential utility of NUVIGIL in managing the depressive episodes in bipolar I disorder," said Dr. Lesley Russell, Cephalon's EVP and chief medial officer.

Next comes Phase III trials in bipolar patients. And if Nuvigil performs, that would open up a huge new market for the drug. As the company's press release notes, some 2 million adults suffer from the psychiatric disorder. That's huge, especially compared with the sleep apnea-sufferer/narcoleptic/shift-worker population now covered by Provigil and Nuvigil's FDA approvals.

Meanwhile, Cephalon is prepping for its Nuvigil launch, planned for the third quarter of 2009--and shareholders chuffed by the new trial results for Nuvigil are bidding up Cephalon stock. Shares jumped by 6.6 percent to $67.38 in midday trading.

- read the Cephalon release
[1]- check out the stock story [2] from the AP

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FTC sues Cephalon for blocking generics [5]
Provigil - Top 10 Warnings and Recalls [6]