The FDA is working to collect these answers to help guide their drug approval process. The FDA’s “Voice of the Patient” aims to “…more systematically gather patients’ perspectives on their condition and available therapies to treat their condition.” This initiative is part of the FDA’s program of incorporating Enhancing Benefit-Risk Assessment in Regulatory Decision-Making.
For instance, did you know that excessive daytime sleepiness was the most significant symptom affecting patients with nacrolepsy’s daily lives? Probably so. You may not know, however, that…
the effects of EDS go far beyond feeling tired or falling asleep during the day. Because of EDS, they constantly battle “brain fog” and other cognitive impairments, automatic behaviors, and chronic sleeping deprivation.
While EDS is the most significant and well known symptom, other symptoms include cataplexy, hallucinations or sleep paralysis. For patients, these symptoms are often uncontrollable and/or unpredictable and the loss of control can be terrifying to patients. Other side effects include insomnia, weight gain, mood fluctuations, and depression, all of which have a significant impact on the lives of patients with narcolepsy.