Marking a quick clinical win with its $2.37 billion acquisition of Avadel, Alkermes reported on Tuesday that its Phase 3 trial of its sodium oxide salt Lamuris met its primary endpoint and all key secondary endpoints in a rare sleep disorder.
The positive results from Revitalyz’s clinical trial for idiopathic hypersomnia come three months after Alkermes acquired Lumryz in completing its acquisition of Avadel. By demonstrating the ability to significantly reduce daytime sleepiness and other symptoms, Lumryz is one step closer to helping Avadel investors realize the full value of this transaction.
Alkermes’ $2.37 billion offer includes a cash payment of $21 per Avadel share, as well as a contingent value right of $1.5 per share related to the potential FDA approval of Lumryz for idiopathic hypersomnia by the end of 2028.
Based on the positive Phase 3 results, Alkermes now plans to file for FDA approval by the end of 2026, potentially allowing for an early 2028 launch. If approved, Lumryz would add further pressure to Jazz Pharmaceuticals’ blockbuster sodium oxybate product, Zywab, whose primary growth driver is the idiopathic hypersomnia indication it acquired in 2021.
Lumrise has been approved since 2023 to treat sudden muscle weakness and excessive daytime sleepiness in patients with narcolepsy.
Although detailed data on Revitalyz will not be available until a future medical conference, Alkermes’ May 12 press release described the results as a home run.
Revitalyz is a placebo-controlled study in which patients either continue taking Lumryz or stop taking the sodium oxybate product in order to receive a placebo. Idiopathic hypersomnia is a rare neurological sleep disorder in which a person feels sleepy during the day despite a full night’s sleep.
Regarding the trial’s primary endpoint, Lumryz demonstrated a statistically significant improvement in excessive daytime sleepiness compared to placebo, with a p-value of less than 0.0001, as measured by change in Epworth Sleepiness Scale (ESS) scores during the two-week washout period, Alkermes said.
In addition, the trial’s secondary endpoints showed that patients who switched to placebo had statistically significant worsening of symptoms on the 7-point self-administered PGI-C questionnaire and the IHSS, a 14-item questionnaire that assesses three symptoms of idiopathic hypersomnia: excessive daytime sleepiness, prolonged nighttime sleep, and sleep inertia. In both cases, the p-value was less than 0.0001.
Alkermes’ expectations for Lumrise’s market opportunity in idiopathic hypersomnia are “very high,” Chief Commercial Officer Todd Nichols said on the company’s first-quarter earnings call last week.
He classified the condition as an “untapped category,” with as many as 40,000 patients diagnosed, but that number is “underestimated,” he said, noting that Zywab is the only FDA-approved product on the market.
In the first quarter of 2026, Lumryz generated approximately $72 million in revenue. That includes $39.5 million since Alkermes acquired it in mid-February. The company expects full-year sales of the drug to be between $350 million and $370 million, according to last week’s quarterly update.
For Xywav, Jazz reported an 18% year-over-year increase in first-quarter revenue to $408 million.
Recognizing the unmet need in idiopathic hypersomnia, Alkermes is also testing the orexin-2 receptor agonist alixorexton in sleep disorders. This program has received the most attention among investors, and the acquisition of Avadel has increased interest in the potential combination of Ramrise and OX2R drugs.
Alkermes has heard frequently from clinicians about the proposal, and the company is interested in starting a clinical program “over time,” the company said on its first quarter conference call last week.
“We’re not going to start right away,” Pops added. “We need to get other things done first, and that is the registration program for alixorexton as a monotherapy. But I think there is growing interest in understanding both the nocturnal and daytime aspects of this disease.”
