According to a story from Biotech 365, the biopharmaceutical company Avadel Pharmaceuticals plc recently announced that it has completed enrollment for its phase 3 clinical trial. This trial will test the company’s once per day formulation of sodium oxybate, known as FT218, as a treatment for cataplexy and excessive daytime sleepiness associated with narcolepsy, a rare sleep disorder. The enrollment target was 205 patients. Other patients that were currently involved in the trial screening process will be enrolled if they satisfy the relevant criteria.
Narcolepsy is a neurological disorder that affects sleep. Patients with narcolepsy have a decreased ability to regulate their cycles of sleeping and wakefulness. The exact cause of narcolepsy is not well known. There are a number of risk factors for the condition however, such as family history, exposure to pesticides, or prior brain injury, such as a stroke or tumor. The most well known symptom of narcolepsy is excessive sleepiness during the day, often to the extent that a patient may fall asleep suddenly during their regular activities. This can occur even after a full night of sleep; patients are unable to sleep as deeply as an unaffected person. Other symptoms include cataplexy (temporary periods of paralysis), hallucinations, sleep paralysis, insomnia, and unexpected weight gain. There is no cure for narcolepsy. Treatments for the condition include stimulants such as amphetamines and modafinil. Most patients cannot control their symptoms entirely. To learn more about narcolepsy, click here.
Avadel hopes to announce topline findings from this trial by the second quarter of next year. FT218 is a new formulation of a widely used treatment for narcolepsy. Sodium oxybate is often used to help treat cataplexy and excessive daytime sleepiness, but in its current form it must be taken twice every 24 hours. FT218 is an all-new formulation that will allow for once per 24 hour dosing thanks to Avadel’s innovative, proprietary Micropump technology. This allows for an oral suspension with extended release properties, improving quality of life for narcolepsy patients and making treatment adherence easier.
FT218 has previously earned Orphan Drug designation from the US Food and Drug Administration (FDA) as a treatment for narcolepsy symptoms.