Acadia Pharmaceuticals Inc. (ACAD)

[north40000]

https://ih.advfn.com/p.php?pid=nmona&article=75795179

"Dementia-Related Psychosis Includes Psychosis in Patients with Alzheimer’s Disease, Dementia with Lewy Bodies, Parkinson’s Disease Dementia, Vascular Dementia, and Frontotemporal Dementia

FDA Grants Breakthrough Therapy Designation to Pimavanserin for Dementia-Related Psychosis

Conference Call to Be Held Today at 5:00 pm ET to Discuss Phase III Development Program

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced the initiation of HARMONY, a Phase III study to evaluate pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis, a serious medical condition for which there is no therapy approved by the U.S. Food and Drug Administration (FDA). The company also announced that the FDA has granted Breakthrough Therapy Designation to pimavanserin for dementia-related psychosis. Dementia-related psychosis includes psychosis in patients with Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia.

If the clinical development program is successful, and pimavanserin is ultimately approved by the FDA for the treatment of dementia-related psychosis, it would represent a significant expansion of the approved use of pimavanserin. Currently, pimavanserin is the only drug approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. It is marketed under the trade name NUPLAZID®....[more]"