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Pfizer reports positive results on Lyrica for RLS symptoms: Two Phase 3 clinical trials, no NDA at this time

January 9, 2012

After substantial investment in a number of clinical trials, including encouraging results from a Phase 2b clinical trial and two Phase 3 clinical trials, Pfizer announced that it will not seek FDA indication of Lyrica for the treatment of restless legs syndrome (RLS), recently renamed Willis-Ekbom Disease. Why?

European Commision Re-Approves Neupro For Parkinson's Disease and RLS

July 7, 2009

Analysis of:UCB Brings Neupro(R) Back To All Patients In Europe | www.medicalnewstoday.com

UCB's Neupro(R) (rotigotine) transdermal patch is back on the market in Europe for both Parkinson's Disease and RLS, which will benefit many patients with either of these disorders. Hopefully, the FDA will consider returning Neupro to the market in the United States for Parkinson's Disease and eventually for RLS. The advantage of a transdermal patch is the sustained release of lower doses of medicine, thereby decreasing the potential and intensity of side effects, especially habituation and augmentation, that are problems with pill delivery of dopamine precursor, l-dopa and dopamine agonists (though less than with the dopmaine precursor).

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

April 16, 2009

Analysis of:Cephalon to apply for FDA approval for Nuvigil for jet lag | www.reuters.com

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.

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