Avadel Pharmaceuticals Receives Unanimous Appeals Court Affirmation for LUMRYZ FDA Approval

Avadel Pharmaceuticals (NASDAQ:AVDL) is one of the most undervalued small-cap stocks to buy according to analysts. On June 30, Avadel Pharmaceuticals announced that the US Court of Appeals for the District of Columbia Circuit (Appeals Court) unanimously affirmed a previous decision by the US District Court for the District of Columbia (District Court).

This ruling was in favor of the US FDA regarding its approval of LUMRYZ (sodium oxybate), which is a once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness/EDS in patients 7 years of age and older with narcolepsy. The lawsuit had been brought by Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ).

The ruling confirms the FDA’s finding, which the Appeals Court noted was undisputed, that LUMRYZ’s once-at-bedtime dosing offers clinical superiority to all first-generation, immediate-release oxybates and represents a major contribution to patient care. Avadel Pharmaceuticals intends to continue advancing its commercial strategy to transform the sleep treatment paradigm for the narcolepsy community and increase the number of patients treated beyond the current thousands.

Avadel Pharmaceuticals (NASDAQ:AVDL) is a biopharmaceutical company in the US. Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ) identifies, develops, and commercializes pharmaceutical products in the US, Europe, and internationally.

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Disclosure: None. This article is originally published at Insider Monkey.