Drugs

Alkermes Reports Phase 2 Results for Narcolepsy Drug

Alkermes says that its investigational once-daily therapy alixorexton significantly improved wakefulness and reduced daytime sleepiness in patients with narcolepsy Type 2 (NT2), meeting both primary endpoints in the company’s Vibrance-2 Phase 2 clinical trial. The company says the data highlight alixorexton — the first oral orexin 2 receptor agonist to show efficacy in a large NT2 study — as a potential first-in-class treatment for the rare neurological disorder. Alkermes said the findings, combined with positive data from its earlier Vibrance-1 trial in narcolepsy Type 1, will support the launch of a global Phase 3 program in early 2026.

In Vibrance-2, 93 adults with NT2 were randomized to receive one of three once-daily doses of alixorexton (10 mg, 14 mg, or 18 mg) or placebo for eight weeks, according to the company. The study met its dual primary endpoints, showing statistically significant and clinically meaningful improvements on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS). The 14 mg and 18 mg doses achieved statistical significance on MWT (p<0.05), while the 18 mg dose was significant on ESS (p<0.05), Alkermes adds.

Alixorexton was generally well-tolerated across all dose groups, Alkermes says, adding that most adverse events were mild to moderate, with no serious treatment-emergent adverse events or notable safety signals in laboratory or cardiac assessments. Common side effects included increased urination, insomnia, dizziness, headache, and urinary urgency. Roughly 95% of participants completed the trial and entered an ongoing open-label extension phase, it says.

Alkermes plans to present the full data from the Vibrance-2 study, including exploratory results on cognition and fatigue, at an upcoming scientific meeting.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome