Avadel Pharmaceuticals plc has submitted an amendment to the US Food and Drug Administration (FDA) requesting final approval for Lumryz (sodium oxybate) to treat cataplexy or excessive daytime sleepiness in adults with narcolepsy.
Lumryz received tentative FDA approval last July, with final approval pending disposition of US patent No. 8,731,963 (the REMS patent), listed in the FDA’s Orange Book, to resolve patent or exclusivity issues. Avadel’s latest submission follows a panel decision by the United States Court of Appeals for the Federal Court on Feb. 24 that will result in the delisting of the REMS patent.
“We look forward to working with FDA to bring Lumryz to all eligible patients as soon as possible,” says Greg Divis, CEO at Avadel Pharmaceuticals, in a press release. “The value proposition of Lumryz, demonstrated by its important benefit to people living with narcolepsy, has been our driving motivation throughout this process, and we stand ready to bring Lumryz to the narcolepsy community following an approval.”
Based on patient and physician research, Avadel estimates the total potential patient population for once-at-bedtime Lumryz could be greater than 30,000 and expects Lumryz, if approved, to be the treatment of choice for patients suffering from narcolepsy-related excessive daytime sleepiness or cataplexy.
The current twice-nightly oxybate market for narcolepsy in the US is comprised of approximately 16,000 patients, Avadel estimates in a press release. The company further notes that, in the last three years, around 10,000 to 15,000 patients have discontinued their twice-nightly oxybate use, many due to complications associated with middle-of-the-night dosing.
Avadel is currently evaluating the long-term safety and tolerability of Lumryz in the open-label RESTORE clinical study.