Avadel Pharma says its sleep disorder drug remains under FDA review

FDA delays decision on Avadel's sleep disorder drug

Avadel Pharmaceuticals said on Tuesday that the U.S. Food and Drug Administration (FDA) has extended the review of its investigational drug for treating sleep-wake disorders to June 28. The drug, known as FT218, is an investigational therapy for narcolepsy and other sleep-wake disorders that cause excessive daytime sleepiness. Avadel originally submitted a New Drug Application (NDA) for FT218 in December 2021, with a Prescription Drug User Fee Act (PDUFA) goal date of June 28, 2022.

The FDA grants a PDUFA date when it accepts a company's NDA for review. This date represents the target date for the FDA to make a decision on whether to approve the drug. However, the FDA can extend the review period to request additional information or conduct further analysis. Avadel said the FDA had requested additional information and data on FT218, which the company has provided.

Extension of NDA review date

The extension of the NDA review date is a setback for Avadel, which had been hoping to launch FT218 in the United States later this year. However, it is not uncommon for the FDA to request additional information or data during the review process. Avadel said it is working closely with the FDA to provide the necessary information and data as quickly as possible.

What is FT218?

FT218 is a small molecule that targets the orexin system, which is involved in the regulation of sleep and wakefulness. Orexin deficiency has been shown to cause narcolepsy and other sleep-wake disorders. FT218 is designed to activate the orexin system and promote wakefulness.

What are the potential benefits of FT218?

FT218 has the potential to provide several benefits over existing treatments for narcolepsy and other sleep-wake disorders. First, FT218 is a once-daily oral medication, which is more convenient than current treatments that require multiple doses per day. Second, FT218 has a rapid onset of action, which can help patients fall asleep more quickly and stay asleep longer. Third, FT218 has been shown to be effective in reducing excessive daytime sleepiness, which can improve patients' quality of life.

What are the potential risks of FT218?

The most common side effects of FT218 are nausea, headache, and dizziness. These side effects are usually mild and go away within a few days. However, FT218 can also cause more serious side effects, such as hallucinations, psychosis, and suicidal thoughts. These side effects are rare, but they are important to be aware of.

Avadel is conducting a Phase 3 clinical trial to evaluate the safety and efficacy of FT218 in patients with narcolepsy. The results of this trial are expected to be released later this year.