Cephalon to apply for FDA approval for Nuvigil for jet lag

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Published at: www.reuters.com

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

NUVIGIL for Jet Lag -- An Important Broad New Indication for Cephalon

June 2, 2009

NUVIGIL, Cephalon's single isomer longer effective half-life follow-up product to Provigil is coming to market only after careful strategic planning.  While extremely successful, Provigil, a unique wake promoting agent, suffered in many ways.  When introduced, it had only FDA approval for narcolepsy, a relatively uncommon, yet severe sleep disorder.  Sales increased markedly when Provigil became approved for other common conditions associated with excessive daytime sleepiness (EDS), treated obstructive sleep apnea with residual EDS and sleep wake shift disturbance (SWSD). If approved for Jet Lag, there is the promise that Nuvigil will become available for an increasing enlarging marketplace.

Jet Lag a Forme Fruste of Shift Work Insomnia

April 23, 2009

Analysis by: GLG Expert Contributor

1.Shift work insomnia, an approved indication for provigil, is both vastly underdiagnosed and under treated. Jet lag is indeed a forme fruste of this condition 2. Currently available techniques for coping with Jet lag are either ineffective ( such as over the counter stimulants and sedatives) or onerous,( chronotherapy involving shifting bedtime). 3. Nuvigil a superb agent with low risk for abuse should be approved for jet lag dyssomnia, and should expand its market vastly.

Nuvigil for Jet lag

April 21, 2009

Analysis by: GLG Expert Contributor

This is an isomer of Provigil, with evidence of being longer acting. Previous attempts to get approval for Provigil have failed. This is a very big market.  As a presctription drug, like Provigil, it could be prescribed of label that has been one of Cephalon's lead products but patent for it may run out soon.  Itis likely to be at least as effective4 as Provigil and generic modafinil may offer stiff competition. Melatonin, easily available OTC, has often been recommended and may have some merit.

Nuvigil: reduced sleepiness in people with jet lag traveling East from the USA to France.

April 16, 2009

Analysis by: GLG Expert Contributor

Nuvigil (armodafinil, Cephalon: CEPH), was reported to reduce sleepiness associated with jet lag in people who traveled east from the United States to France.  Nuvigiol should help to ease the transition from time zone travel, but some aspects of sleep, namely REM sleep shifting to the new time zone, will take several days.  Nuvigil should increase job performance, functional behavior, ease the discomfort and safety risks during jet lag effects, during the adjustment of the biological sleep rhythm to the new time zone. The wake promoting Scedule IV medication, Provigil, has been FDA approved and helpful for patients with narcolepsy (since 1998), sleep apnea with persisting excessive sleepiness and shift workers, for both acute and long-term use. It has a good safety and effectiveness track record and with Xyrem, has been very beneficial for patients with narcolepsy over long term use.

No need to lag as the day goes on for sleep apnea, narcolepsy and jet laggers

April 16, 2009

Analysis by: GLG Expert Contributor

An FDA approved alternative to modafinal will soon be available that will allow patients who suffer from sleepiness during the wrong parts of the day . Modafinil  is not a scheduled drug like the amphetamines and provided a much needed alternative. Modafinil has been tweaked to armodafinil (Nuvigil is the brand name, to be launched by Cephalon)  to provide a longer course of action  so that dosing once daily will allow someone to stay alert  until it is time for them to get some zzzs when they desire. This will help those who suffer from jet lag, narcolepsy, obstructive sleep apnea, and shift work disorders.

Shooting Flleas with Elephant Guns

April 16, 2009

Analysis by: GLG Expert Contributor

Nice idea if it truly is effective, but I do not see much potential for what is a very self-limited "disorder."

Cephalon’s Nuvigil, A Treatment for Jet Lag and Bipolar Depression?

April 14, 2009

Analysis by: GLG Expert Contributor

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.  

Cephalon's Nuvigil

April 13, 2009

Analysis by: GLG Expert Contributor

I feel that Cephalon will have a lot of success with Nuvigil. Provigil has been used OFF-Label for many years to treat Jet-Lag.