Positive Phase 3 Data for Oral OSA Medication AD109, FDA Clears First Blood Test for Alzheimer Disease, DHE Autoinjector Treatment Approved for Migraine

WATCH TIME: 4 minutes

Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

Newly announced results from the phase 3 SynAIRgy trial (NCT05813275) showed that AD109 (Apnimed), a first-in-class, once-daily oral pill, met its primary end point in reducing apnea-hypopnea index (AHI) across a broad range of patients with mild, moderate, and severe obstructvie sleep apnea (OSA). Based on these findings, Apnimed plans to submit a new drug application (NDA) to the FDA in early 2026 for AD109 as a potential treatment of OSA.1 Considered the largest such drug trial for OSA, SynAIRgy included 646 adults with the disease who were intolerant of or currently refusing continuous positive airway pressure (CPAP). Coming into the study, 34.4% of patients had mild OSA, 42.4% had moderate, and 23.2% had severe. Overall, treatment with AD109, a fixed dose combination of aroxybutynin 2.5 mg/atomoxetine 75 mg, led to a statistically significant change in AHI, the primary end point, over a 26-week period relative to placebo (P = .001).

According to a new announcement, the FDA has cleared Fujirebio’s Lumipulse G p-tau217/ß-Amyloid 1-42 Plasma Ratio, a diagnostic blood test, for the early detection of amyloid plaques associated with Alzheimer disease (AD) in adults aged 55 and older. With the decision, it becomes the first such in vivo blood test used in the diagnosis of AD.The test operates on the Lumipulse G platform, a fully automated system that uses chemiluminescent enzyme immunoassay technology to quantify biomarkers with high sensitivity and precision. The p-tau217 protein, associated with neurofibrillary tangles in AD, and ß-Amyloid 1-42, which forms amyloid plaques, are measured in plasma using the Lumipulse G p-tau217/ß-Amyloid 1-42 Plasma Ratio to distinguish amyloid-positive individuals from amyloid-negative ones, giving patients a non-invasive alternative for early AD detection.

According to a new announcement, the FDA has granted approval to Amneal Pharmaceuticals’ dihydroergotamine mesylate injection, marketed as Brekiya, as the first dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and cluster headache in adults. The company noted that the therapy contains the same DHE used in hospitals but in a ready-to-use, subcutaneous autoinjector form that can be self-administered. The device delivers 1 mg dose into the thigh and does not require refrigeration, assembly, or priming. The hope is that the formulation may provide sustained pain relief and is intended for patients who experience issues with oral therapies, such as inefficacy, nausea, vomiting, or delayed dosing.

For more direct access to expert insight, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.