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Cephalon’s Nuvigil On Course For Jet-Lag Filing

This article was originally published in The Pink Sheet Daily

Executive Summary

Wakefulness drug completes Phase III with flying colors and targets tricky $100M market.

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Nuvigil Jet Lag Indication Could Triple Potential Patients

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Nuvigil Jet Lag Indication Could Triple Potential Patients

Cephalon's sNDA, if approved, will create the marketing challenge of reaching a population of acute, not chronic, suffers.

R&D IN BRIEF

BioXell overactive bladder drug stops going: Top-line results from a European Phase IIb study of BioXell's OAB drug elocalcitol show the drug failed to demonstrate a statistically significant effect on the primary endpoint of change in volume at first involuntary contraction following four weeks of treatment, the Milan, Italy-based Roche spinoff announced April 8. The study involved 257 patients randomized to placebo, 75 mcg or 150 mcg elocalcitol. Results were mixed on secondary endpoints: in the intent-to-treat population, a significant improvement was observed in bladder volume at first desire to void, along with significant improvement in incontinence episodes in the modified ITT population. Numerical improvements were seen for OAB symptoms in all treatment groups, with a strong dose-related trend in patient's perception of bladder condition in the ITT population that reached statistical significance in the per protocol analysis. The company immediately put development of another candidate, BXL746, for post-surgical adhesions, and a Phase II study of elocalcitol in male infertility on hold while it assesses options

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