FDA Grants Tentative Approval to Narcolepsy Agent; Neurologists Say They Are Likely to Prescribe It

A new formulation of a narcolepsy drug may get uptake among providers, according to Zitter Insights research. But payers indicate that they are likely to require patients to fail at least one generic drug before getting access to the new agent and other branded medications.

On July 19, Avadel Pharmaceuticals plc said that the FDA had granted tentative approval to its Lumryz (sodium oxybate) for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. The drug — which is also known as FT218 — is a once-at-bedtime extended-release version of Jazz Pharmaceuticals plc’s Xyrem, which requires one dose at bedtime and then another dose between two-and-a-half to four hours later.

Tentative approval means that Lumryz has satisfied all the FDA’s quality, safety and efficacy standards needed for approval, but final approval is dependent on a Jazz patent. Avadel filed a motion in the U.S. District Court for the District of Delaware on June 23 asking to delist the so-called “REMS patent” — which expires June 17, 2023 — from the FDA’s Orange Book. If that happens, it “could provide a pathway for a final approval” before June 2023. In response, Jazz filed a patent infringement lawsuit against Avadel in July.

Drugs.com lists 500 mg/mL of Xyrem oral liquid for 180 milliliters as more than $6,338.

For the Managed Care Biologics and Injectable Index: Q3 2020, between Aug. 25, 2020, and Sept. 28, 2020, Zitter Insights polled 50 commercial payers covering 127.5 million lives and 50 neurologists about two agents that were in the late-stage narcolepsy pipeline: Lumryz and NLS Pharmaceutics AG’s Quilience (mazindol ER). The latter treatment has a dual mechanism of action as a partial orexin agonist and pan-monoaminergic reuptake inhibitor and has once-daily dosing. It is an extended-release formulation of mazindol, which was on the market for nearly 30 years as Novartis Pharmaceuticals Corp.’s obesity drug Sanorex before it was voluntarily withdrawn in 2009. That withdrawal was not due to safety or efficacy issues.

Zitter Insights and AIS Health are both MMIT companies.

Assuming those two pipeline drugs are approved, payers covering 96% of lives said they anticipated requiring failure of a generic narcolepsy agent before covering a branded agent. Those with 78% of lives said they expect to prefer some branded therapies over others.

Sixty percent of neurologists said they were likely to prescribe Lumryz, and 64% said the same about Quilience (see chart). Neurologists who said they were likely to prescribe the two drugs over other branded therapies were most likely to prescribe them over Xyrem: 77% said they were most likely to prescribe Lumryz over Xyrem, while 60% said they would prescribe Quilience over the Jazz medication.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jbrown@aishealth.com.

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