Alkermes’ Lumryz, from $2.4B Avadel buy, hits phase 3 mark in IH

Alkermes has chalked up a quick clinical win from its $2.37 billion acquisition of Avadel, reporting Tuesday that a phase 3 study of the sodium oxybate Lumryz met all primary and key secondary endpoints in a rare sleep disorder. The positive readout from the Revitalyz trial in idiopathic hypersomnia comes three months after Alkermes bagged Lumryz upon closing the Avadel buyout. By demonstrating its ability to significantly reduce daytime sleepiness and other symptoms, Lumryz is moving one step closer to helping Avadel investors realize the deal's full value. Besides $21 per Avadel share in cash payment, Alkermes’ $2.37 billion offer includes a $1.5-per-share contingent value right tied to the potential FDA approval of Lumryz in idiopathic hypersomnia by the end of 2028. Based on the positive phase 3 results, Alkermes now plans to file for approval with the FDA by the end of 2026, potentially making an early 2028 launch possible. If approved, Lumryz would add more pressure to Jazz Pharmaceuticals’ blockbuster sodium oxybate product Xywav, which counts the idiopathic hypersomnia indication—obtained in 2021—as its main growth driver. Lumryz has been approved to treat sudden muscle weakness or excessive daytime sleepiness in patients with narcolepsy since 2023. While detailed data from Revitalyz won’t be available until a future medical meeting, Alkermes’ May 12 press release depicted the results as a home run. Revitalyz is a placebo-controlled study in which patients either stayed on Lumryz or withdrew from the sodium oxybate product to receive a placebo. Idiopathic hypersomnia is a rare neurological sleep disorder that causes people to be sleepy during the day despite having a full night of sleep. On the trial’s primary endpoint, Lumryz showed statistically significant improvements in excessive daytime sleepiness versus placebo as measured by the change in Epworth Sleepiness Scale (ESS) score during the two-week withdrawal period, with a p-value below 0.0001, according to Alkermes. In addition, on the trial’s secondary endpoints, patients who switched to placebo had statistically significant worsening of symptoms on the 7-point self-administered PGI-C questionnaire and on IHSS, a 14-item questionnaire that assesses three idiopathic hypersomnia symptoms: excessive daytime sleepiness, prolonged nighttime sleep and sleep inertia. In both cases, the p-value was below 0.0001. Alkermes’ expectations for Lumryz’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 labeled the condition as an “underdeveloped category,” with 40,000 patients being diagnosed—a number that he said is “underrepresented” —and Xywav as the only FDA-approved product on the market. Over the first quarter of 2026, Lumryz generated sales of about $72 million, including $39.5 million since Alkermes took over in mid-February. For the full year, the company expects the drug’s sales to reach between $350 million and $370 million, according to a quarterly update last week. For Xywav, Jazz reported an 18% sales increase year over year to $408 million in the first quarter. Recognizing the unmet need in idiopathic hypersomnia, Alkermes is also testing its orexin 2 receptor agonist alixorexton in the sleep disorder. The program has been a top focus among investors, and the Avadel acquisition fueled interest in potential combinations between Lumryz and an OX2R drug. Alkermes has heard frequently of the proposal from clinicians, and the company is interested in launching a clinical program “over time,” CEO Richard Pops said on the first-quarter call last week. “We’re not going to start that right away,” Pops added. “We need to finish some other things first, namely the registration program for alixorexton as monotherapy. But I think there’s increasing interest in understanding both the nighttime and the daytime aspects of the disease.”