An Experimental Narcolepsy Treatment Was Just Granted Orphan Drug Status

According to an article from FinancialBuzz, the pharmaceutical company Avadel announced that its product FT 218 has been granted orphan drug status by the Food and Drug Administration (FDA) as a treatment for narcolepsy.

Orphan drug status is an ordinance meant to incentivize the development of treatments for rare diseases. A drug can only receive orphan drug status if it is targeting a disease that affects less than 200,000 people per year. When a medication receives orphan drug status, the company is granted exclusive rights to continue the development of the treatment. The company is also granted a period of market exclusivity for seven years as a way to ensure that the company makes some return for their investment in development of the drug. The status also provides some financial incentives by cutting costs and waiving some fees that the company would have to pay. The status is normally only reserved for medications that are deemed to have the potential to treat a disease that has limited or no current options for treatment, or a medication that could majorly improve treatment.

Narcolepsy is a long term neurological condition that causes a person to have problems regulating their sleeping-wakefulness cycles. The primary symptom is seemingly random periods of excessive daytime sleepiness. These can occur at almost anytime throughout the day an can last several minutes or seconds. Many people with the condition also experience cataplexy, a sudden loss of muscle strength. Strong emotional experiences can trigger these episodes. Some people also experience sleep paralysis and hallucinations when they fall asleep or upon waking. People with narcolepsy generally get the same amount of sleep that a healthy person would, but often it is of lesser quality. Cause of this disorder is unknown. To learn more about narcolepsy, click here.
The suddenness and unpredictability of narcolepsy means that it can be quite debilitating, and there are currently few treatment options for it. Orphan drug status for FT 218 means that improvement could be on the way, however. FT 218 was given the status because it is projected to be more effective than current treatments and has had less side effects so far.

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