Implications

Cephalon’s Nuvigil (armodafinil)  is already making headway toward a broader range of clinical indications than its sister compound Provigil (modafinil), which will be open to genericization  in a few years.  Excessive sleepiness associated with jet lag, Cephalon’s next step with Nuvigil, is a narrower clinical target as compared to the big news last month reported by Cephalon’s that it will be advancing Nuvigil into Phase III trials as a treatment for bipolar depression, based on significant results from a Phase II study.  

Analysis

It’s hard to draw any distinct clinical impression on Nuvigil before its anticipated market launch later this year.  However, looking beyond excessive sleep associated with jet lag, itself  a smaller, niche clinical population that involves sporadic dosing rather than chronic daily dosing, Cephalon hopes to accomplish even more with Nuvigil than it did with Provigil (which had been pulled from development late-stage as an ADHD treatment).   Bipolar depression, as well as other potential indications in registrational trials such as adjunctive treatment for schizophrenia, is where the long-term clinical potential lies for this drug. glgroup.com/