Acadia announces positive results of Phase 3 trial to treat psychosis
Category: #health  By Pankaj Singh  Date: 2019-12-06
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Acadia announces positive results of Phase 3 trial to treat psychosis

Acadia Pharmaceuticals, a renowned US-based biopharmaceutical company dedicated to the development of treatments for central nervous system disorders, reportedly announced positive outcomes from its Phase 3 HARMONY study of pimavanserin.

The company announced these positive outcomes during the 12th CTAD (Clinical Trials on Alzheimer’s Disease) meeting being held in San Diego, California between December 4 and 7, 2019.

HARMONY was a relapse prevention, double-blind, placebo-controlled trial in 392 patients for the evaluation of pimavanserin to treat dementia-related psychosis.

Director Emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Jeffrey Cummings, M.D., Sc.D. stated that the outcomes showcased are a crucial advancement for caregivers and patients who struggle with the weight of dementia-related psychosis, a niche where there is no FDA-approved therapy currently available.  

Cummings further added that decreasing the threat of relapse of psychotic symptoms with this margin is a vital and meaningful result. This is because these are very serious events that could further lead to poor patient results and substantial growth in caregiver distress and burden.

The Phase 3 HARMONY trial comprised a 12-week open-label pimavanserin therapy period before the randomization period of the trial. During this open-label therapy period, 61.8% of eligible patients were able to reach to pre-specified criteria for pimavanserin therapy response at week 12 and week 8 both.

For patients in the open-label therapy period, alteration from baseline to week 8 and then to week 12 on the SAPS-H+D (Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions) score increased by 63.0% as well as 75.2% respectively.

President of ACADIA, Serge Stankovic, M.D., M.S.P.H., stated that the company is thrilled to unveil the top-line outcomes from this Phase 3 study to treat dementia-related psychosis. The HARMONY trial was innovated to get solutions for three very important problems. First, during the 12-week open-label period, treatment through pimavanserin indicated a meaningful decrease of the symptoms. Also, a reduction in the stabilization of psychosis through all the five clinically detected subtypes evaluated were seen.

Second, during the 26-week double-blind timeframe, patients dosed with pimavanserin had an almost three-fold decrease in risk of relapse in comparison with patients on placebo. Third, elderly patients suffering from dementia-related psychosis could tolerate pimavanserin well.

The company looks forward to discussing these outcomes with the FDA in the first half of the coming year.

 

 

Source credit: https://ir.acadia-pharm.com/news-releases/news-release-details/acadia-pharmaceuticals-presents-positive-top-line-results?field_nir_news_date_value%5bmin%5d=



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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