Datapoint: FDA Grants Tentative Nod to Xyrem Rival

The FDA last week granted tentative approval to Avadel Pharmaceuticals’ narcolepsy drug Lumryz, a potential rival to Jazz Pharmaceuticals’ Xyrem, pending the resolution of a patent dispute between the two companies. Lumryz’s main advantage over Xyrem is its extended-release formula, whereas Xyrem requires two nightly doses. For the treatment of narcolepsy, Xyrem currently holds covered or better status for 96% of all insured lives in the U.S. under the pharmacy benefit. About 20% of insured lives have preferred access to Xyrem, largely with utilization management restrictions applied.

Source: MMIT Analytics, as of 7/27/22

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