US FDA approves Axsome's drug for Alzheimer's-related agitation - Reuters
US FDA approves Axsome's drug for Alzheimer's-related agitation Reuters
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Notable Quotes
"This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer's disease."
— Marty Makary , Executive
"Auvelity was found to be efficacious for treating agitation in Alzheimer’s disease in two randomized trials and now represents an additional option to address one of the most difficult sequelae of the disease."
— Tracy Beth Hoeg , Academic
"The approval of our first-in-class medication for agitation associated with Alzheimer’s disease marks an important milestone for the millions of patients living with Alzheimer’s disease, their families, and their caregivers."
— Herriot Tabuteau , Executive
"Treatment for agitation associated with Alzheimer’s disease dementia has been a critical unmet medical need."
— Jeffrey Cummings , Academic
"Agitation in patients with dementia due to Alzheimer’s disease is distressful, consequential, and challenging for patients, their caregivers and healthcare providers."
— George Grossberg , Academic
"We believe it is unlikely that Auvelity will receive the black box warning typically associated with antipsychotics, given that it is neither molecularly an antipsychotic nor indicated for the treatment of psychosis."
— Ashwani Verma , Executive
Key People
UBS analyst who estimates market impacts for pharmaceutical products.
Professor and Director of the Division of Geriatric Psychiatry at Saint Louis University School of Medicine.
Chief Executive Officer of Axsome Therapeutics, Inc.
Chambers-Grundy Professor of Brain Sciences at UNLV Kirk Kerkorian School of Medicine.
Author of the article discussing Axsome Therapeutics' FDA approval.
Marty Makary is the FDA commissioner who announced Prasad's departure.
Acting Director of the FDA’s Center for Drug Evaluation and Research.
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<a href="https://news.google.com/rss/articles/CBMiyAFBVV95cUxPWVphYlZWc0RER3F3c09sMXhsQkE4b0lzaXhWM3FYV2lza19mU3Y1WWI4WElZbmxOc3FGUE9UaUN2VmVQYjRuaHJQU0lQS3V5Y2Z5Wk1lVkNGelEyMHMwSXR1YWRWYk9ULV9zTFBvX291RmpHakpodm04MHpfWl9lZlVhVGdiM2tiQ3BWb080NWFrR1VUdUxsb2FmTE5LT2xnSlZrVHotRzY3OHV0d0d2djlUSUVEV3lQeXY5VnBvWWlHUTZZNXd1Yw?oc=5" target="_blank">US FDA approves Axsome's drug for Alzheimer's-related agitation</a> <font color="#6f6f6f">Reuters</font>
The FDA approved Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) for treating agitation in Alzheimer's patients, marking the first non-antipsychotic treatment for this condition.
The FDA approved Axsome Therapeutics' drug, Auvelity, to treat agitation in Alzheimer's patients, offering an alternative to antipsychotic drugs.
Axsome Therapeutics received FDA approval for Auvelity to treat Alzheimer's disease agitation, accessing a $1 billion-plus market and offering a clean label compared to competitors.
The FDA approved Axsome Therapeutics' Auvelity for treating agitation in Alzheimer's disease, providing a new option to ease caregiver burden.
Axsome Therapeutics announced the FDA approval of Auvelity for treating agitation associated with Alzheimer's disease, a first-in-class treatment targeting NMDA and sigma-1 receptors.
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