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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong> <\/p>\nBack to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nUp to 76% of patients with Alzheimer\u2019s disease experience agitation.<\/li>\n Auvelity is the first drug approved for agitation that is not an antipsychotic.<\/li>\n Dizziness and dyspepsia were the most common adverse events.<\/li>\n<\/ul>\nThe FDA has approved Auvelity for treating agitation in patients with dementia due to Alzheimer\u2019s disease, Axsome Therapeutics said in a press release. <\/p>\n
Up to 76% of patients with Alzheimer\u2019s disease experience agitation, including pacing, restlessness and verbal or physical aggression, according to the release. <\/p>\n
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\u201cAlzheimer\u2019s disease agitation is associated with accelerated cognitive decline, placement in assisted living and long-term care facilities, and increased mortality risk,\u201d Jeffrey Cummings, MD, ScD,<\/b> Chambers-Grundy Professor of Brain Sciences at the UNLV Kirk Kerkorian School of Medicine, said in the press release. <\/p>\n
\u201cTreatment for agitation associated with Alzheimer\u2019s disease dementia has been a crucial unmet need,\u201d he said. \u201cThe approval of Auvelity for this condition has the potential to play an important role in patient care for this challenging and impactful symptom.\u201d <\/p>\n
The clinical program that supported this approval included the phase 3 ADVANCE-1 study, which found statistically significant improvement in Cohen-Mansfield Agitation Inventory scores at week 5 with Auvelity (dextromethorphan hydrobromide and buproprion hydrochloride) compared with placebo. <\/p>\n
Also, the proportion of patients with at least minimal improvement in modified Alzheimer\u2019s Disease Cooperative Study-Clinical Global Impression of Change scores was statistically significantly greater in the treatment group, compared with placebo. <\/p>\n
Patients who responded to treatment in ADVANCE-1 then entered the double-blind ACCORD-2 study, which found statistically significantly longer times to relapse in symptom agitation symptoms with treatment at 6 months compared with placebo. <\/p>\n
Dizziness and dyspepsia were the most common adverse reactions during ADVANCE-1. Rates of discontinuation due to an adverse event included 1.3% for the treatment and placebo groups alike. <\/p>\n
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Frank M. Longo<\/b><\/strong><\/p>\n<\/div>\n \u201cFor patients and caregivers, any progress in Alzheimer\u2019s treatment is meaningful. This milestone highlights the advances being made in addressing the day-to-day realities of the disease,\u201d Frank M. Longo, MD, PhD,<\/b> cofounder and chairman of the board at PharmatrophiX, said in a prepared statement provided to Healio. <\/p>\n
\u201cIt reflects the growing momentum in innovative treatments for neurodegenerative diseases and further underscores the continued need for disease-modifying therapies,\u201d Longo said. <\/p>\n
The Alzheimer\u2019s Association said in a separate press release that it welcomes the approval, noting that agitation is among the most difficult symptoms of the disease to manage and that it seriously impacts both patients and their families. <\/p>\n
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Joanne Pike<\/b><\/strong><\/p>\n<\/div>\n \u201cFor too long, people living with Alzheimer\u2019s disease agitation and their families have had limited options, and the options that existed came with significant risks,\u201d Alzheimer\u2019s Association President and CEO Joanne Pike, DrPH,<\/b> said in the release. <\/p>\n
The Alzheimer\u2019s Association further noted that this is the first approval for an agitation treatment in Alzheimer\u2019s disease that is not an antipsychotic. <\/p>\n
\u201cThis approval gives patients, caregivers and clinicians an important new tool, one that works through a different mechanism than antipsychotic medications and that can help address a symptom that profoundly affects quality of life,\u201d Pike said. <\/p>\n
For more information:<\/b> <\/p>\n
Frank M. Longo, MD, PhD<\/b>, <\/b>can be reached at neurology@healio.com.<\/p>\n\n
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