Drugs

Positive Trial Data on Sleep Apnea Drug

Apnimed is announcing positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin and atomoxetine), a once-daily oral pill for treating obstructive sleep apnea (OSA). The company says the LunAIRo study met its primary endpoint, reinforcing earlier findings from the SynAIRgy trial, moving it one step closer to an NDA submission that is being planned for early next year.

In the LunAIRo trial, AD109 demonstrated a statistically significant and clinically meaningful reduction in the Apnea-Hypopnea Index (AHI), a key OSA severity measure, Apnimed says. Patients who received AD109 showed a 46.8% reduction in AHI from baseline after 26 weeks, compared to 6.8% in the placebo group, it says, adding that no serious adverse events related were reported.

AD109 is described as a first-in-class combination of aroxybutynin and atomoxetine that works by enhancing upper airway muscle tone during sleep — targeting the root neuromuscular cause of OSA, rather than relying on mechanical intervention like continuous positive airway pressure therapy.

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