12:00 AM
Sep 30, 2013
 |  BioCentury  |  Regulation

Wake-up call

Narcolepsy patients tell FDA they want a better balance of alertness and sleep

Narcolepsy patients told FDAand companies at the agency's latest patient-focused drug development meeting they want a better balance of alertness and sleep. Specifically, this means better resolution of excessive daytime sleepiness - their worst symptom - and reductions in the sleep disruption side effects associated with current drugs.

It remains to be seen whether anything in the narcolepsy pipeline can achieve that balance.

Narcolepsy is a neurological sleep disorder characterized by four major symptoms: excessive daytime sleepiness (EDS), sleep paralysis, hallucinations and cataplexy, which is a sudden muscular weakness often triggered by strong emotions.

Individual patients may experience varied combinations of these symptoms, and symptom severity varies widely across patients.

The primary symptoms may be accompanied by additional symptoms including restless legs syndrome (RLS), automatic behaviors like sleepwalking and disrupted sleep patterns.

As cataplexy is the only symptom unique to narcolepsy and there are no molecular diagnostics for the condition, diagnosis relies on a battery of questionnaires, sleep latency tests and overnight sleep studies to rule out other sleep disorders, psychological disorders, epilepsy and other causes of persistent fatigue such as chronic fatigue syndrome (CFS).

According to an online report published last year by the University of Maryland Medical Center, most narcolepsy patients are not diagnosed...

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