Waking up in the middle of the night to take a pill is the onerous way patients take the world’s top-selling narcolepsy drug, Jazz Pharmaceuticals’ Xyrem.
But there finally is relief from that challenging regimen as the FDA has blessed a longer-acting, once-at-bedtime treatment. Avadel Pharmaceuticals’ Lumryz is a different formulation of the same drug (sodium oxybate) Jazz has used for its treatment for more than two decades.
The endorsement for Avadel is a major threat to its crosstown rival, also based in Dublin. Jazz raked in sales of $1.98 billion for Xyrem and its reduced-sodium follow-on Xywav last year, accounting for more than half of the company’s 2022 revenue of $3.7 billion.
With the news, Avadel's share price rose 12%.
The FDA tentatively approved Lumryz in July of last year after a phase 3 trial proved its quality, efficacy and safety. But the endorsement was contingent upon the status of a patent owned by Jazz on Xyrem.
In February, Avadel got a key win in the case as a U.S. appeals court ruled that Jazz had to delist its patent, removing it from the FDA’s Orange Book, which is a compilation of patents that cover approved drugs.
With Monday’s approval, the FDA granted Avadel seven years of orphan drug exclusivity.
“Seven years of market exclusivity, combined with our patent protection through early 2042 only enhances the potential of the longer-term growth of Lumryz in the overall narcolepsy market,” Avadel CEO Greg Divis said in a conference call.
Avadel expects the Lumryz to be available in the U.S. in four weeks. The company will price the treatment at $64.67 per gram, executives said during the call. With the highest daily dosing option at nine grams, this would put annual cost of the drug at $212,440 per year, which is comparable to what Jazz charges for Xywav.
As Avadel transitions into a commercial company, a $3 billion-plus market awaits, Divis said.
The key component of sodium oxybate is gamma-hydroxybutyrate, which was used in the 1960s to induce drowsiness during childbirth, The New York Times reports. Decades later, an illegal version of the treatment became known as the “club drug” or “date rape drug.” At lower doses it can provide euphoria and sexual arousal. At higher doses it can induce unconsciousness.
Jazz used the tight controls on the drug to create patents surrounding its safety program. One of those patents was rejected by the court earlier this year when it made its delisting order.