Source: Google NewsPublished on 2021-04-05
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- Benefits of Acadia’s Nuplazid Outweigh Risks for Parkinson’s Psychosis Patients, FDA Reports September 24, 2018 Nearly half a year after news reports surfaced about deaths allegedly linked to Nuplazid (pimavanserin) — a therapy for Parkinson’s patients with disease-related psychosis — the U.S. Food and Drug Administration says it could not find any new or unexpected safety concerns with the controversial treatment. The agency said in a Sept. 20 press release that “after a thorough review, the FDA’s…
- Nuplazid Shows Sustained Easing of Psychosis in Patients in Phase 3 Trial June 8, 2020 Daily use of Nuplazid (pimavanserin) leads to strong and sustained reductions in the frequency and severity of hallucinations and delusions in people with Parkinson’s disease psychosis, according to data from a long-term extension study. These findings, “Improvement and Durability in SAPS-PD Assessment over 10 Weeks of Pimavanserin Treatment for Parkinson’s Disease Psychosis,” were presented at the at the 2020 American…
- Once-a-day Capsule for Nuplazid and Lower Dose Option Approved for Parkinson’s Psychosis Patients July 2, 2018 The U.S. Food and Drug Administration has approved a once-a-day capsule formulation and a lower tablet strength for Nuplazid (pimavanserin), a treatment for the hallucinations and delusions associated with Parkinson’s psychosis. The new formulation — a 34 mg capsule— enables patients to take the recommended oral dose once a day instead of the twice-daily existing 17-mg tablet dose. Also approved…
- #AAN2018 – Real-life Use Supports Nuplazid’s Safety, Efficacy in Treating Parkinson’s Psychosis April 19, 2018 Nuplazid (pimavanserin) is well-tolerated and can lead to clinical improvement in people with Parkinson’s disease psychosis (PDP), according to the results of studies into its real-life use. Acadia will present these data at the 2018 American Academy of Neurology ANN Annual Meeting, taking place in Los Angeles from April 21–27. Nuplazid is an oral medication, approved by the U.S. Food and Drug Administration…
- Nuplazid’s Risks in Treating Parkinson’s Psychosis Don’t Appear Exceptionally High, Experts Say June 11, 2018 The controversy surrounding Nuplazid (pimavanserin), Acadia Pharmaceuticals‘ approved treatment for psychosis in Parkinson’s patients, has made its way to scientific journals. But experts appear to take a more questioning view of the medication’s risks than that aired by general media. A clinical trial comparing the effectiveness and benefits of Nuplazid to other antipsychotics used to treat these patients would be warranted, and ideally…
- FDA Continuing to Monitor Nuplazid Use, Agency Says in Response to Controversial CNN Report April 16, 2018 The U.S. Food and Drug Administration is keeping close watch on the use of Nuplazid (pimavanserin) by Parkinson’s patients with disease-related psychosis, but at present sees no reasons to change the existing warnings placed on the medication — sold by Acadia Pharmaceuticals — when first approved. The FDA stated its position, given in response to a recent CNN report on patient…
- Nuplazid’s Mortality Risk Not Different from Seroquel, Combo Treatment, Study Finds September 28, 2018 Treatment with Nuplazid (pimavanserin) does not lead to a different mortality risk compared to the antipsychotic medication Seroquel (quetiapine), or to combination treatment with both medications, in patients with Parkinson’s psychosis, according to results from a large study. The study, “Mortality in patients with Parkinson disease psychosis receiving pimavanserin and quetiapine” was published in the journal Neurology. In April 2016, Acadia…
- New Phase 3 Trial to Test Nuplazid for Parkinson’s Psychosis in Array of Dementia Patients October 5, 2017 Acadia Pharmaceuticals is starting a new Phase 3 clinical trial testing the efficacy of pimavanserin to treat the hallucinations and delusions associated with dementia-related psychosis in a broad array of patients with Parkinson’s, Alzheimer’s, and many other dementias. Pimavanserin, under the brand name Nuplazid, was approved by the U.S. Food and Drug Administration (FDA) to treat dementia-related psychosis in Parkinson’s patients in 2016. This trial, and the Breakthrough…
- Nuplazid Eases Depression in Parkinson’s Patients, Phase 2 Trial Shows October 1, 2019 Treatment with Nuplazid (pimavanserin), approved in the U.S. for treating hallucinations and delusions associated with Parkinson’s psychosis, eased depression and sleep problems in patients with Parkinson’s, according to results from a Phase 2 clinical trial. The research, “Open-Label Study of Pimavanserin Patients With Comorbid Parkinson’s Disease and Depression,” was presented at the 2019 International Congress of Parkinson’s Disease and Movement Disorders in Nice,…
- Long-term Nuplazid Safe, Well-tolerated by Parkinson’s Psychosis Patients, Extension Study Shows June 5, 2020 Nuplazid (pimavanserin), an approved therapy for treating hallucinations associated with Parkinson’s disease psychosis, is generally safe and well-tolerated in the long run, and may be associated with reduced mortality in this particular patient population, findings from a long-term extension study suggest. The results were presented at the 2020 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, which was held virtually due…
- Long-term Nuplazid Safe, Well-tolerated by Parkinson’s Psychosis Patients, Extension Study Shows June 5, 2020 Nuplazid (pimavanserin), an approved therapy for treating hallucinations associated with Parkinson’s disease psychosis, is generally safe and well-tolerated in the long run, and may be associated with reduced mortality in this particular patient population, findings from a long-term extension study suggest. The results were presented at the 2020 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, which was held virtually due…
- Nuplazid Review Endorses Treatment, But Pinpoints Additional Study Needs January 9, 2018 Even though 60 percent of Parkinson’s Disease patients develop psychotic symptoms, it was only in 2016 that a treatment for the condition was approved. Nuplazid (pimavanserin) employs an entirely different mechanism to control psychotic symptoms compared to the bulk of antipsychotic medications on the market. The review, “Pimavanserin, a novel antipsychotic for management of Parkinson’s disease psychosis,” took a look at…
- Nuplazid and Clozaril Are Most Reliable Parkinson’s Psychosis Therapies, Review Finds March 7, 2018 The antipsychotics Nuplazid (pimavanserin) and Clozaril (clozapine) are the only therapies shown to improve Parkinson’s disease psychosis (PDP) symptoms without impairing motor function, in double-blind, placebo-controlled clinical trials, according to a review. The study, “Pharmacological interventions for psychosis in Parkinson’s disease patients,” was published in the journal Expert Opinion on Pharmacotherapy. Parkinson’s disease psychosis is a non-motor symptom that causes patients to experience hallucinations…
- Study Reviews Use of Acadia’s Nuplazid as Treatment for Psychosis Linked to Parkinson’s Disease June 19, 2017 Acadia Pharmaceuticals‘ Nuplazid (pimavanserin) is a reliable treatment to manage hallucinations and delusions associated with Parkinson’s disease psychosis (PDP), but its high cost and restricted access may limit its use in clinical practice, a new study says. The review, “Pimavanserin: A Novel Antipsychotic for Parkinson’s Disease Psychosis,” appeared in the journal Annals of Pharmacotherapy. Pimavanserin is a selective serotonin inverse…
- Psychosis Treatments October 28, 2019 Psychosis Treatments PSYCHOSIS TREATMENTS Generic Brand Form Indication Adult Initial Dose Adult Dose Titration First-Generation Antipsychotics chlorpromazine HCl — tabs Psychosis. Mania Less acutely disturbed: 25mg three times dailyOutpatient: 10mg 3–4 times daily or 25mg 2–3 times dailySevere cases: 25mg three times daily Inpatient: 500–1000mg/dayLess acutely disturbed: 400mg/dayOutpatient: 200–800mg/day Increase dose gradually until symptoms are controlled. Continue optimum dosage for…
- FDA Rejects Pimavanserin sNDA for Dementia-Related Psychosis April 8, 2021 The Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Acadia Pharmaceuticals regarding the supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis. The sNDA submission was supported by data from the pivotal phase 3 HARMONY study (ClinicalTrials.gov: NCT03325556) that compared the efficacy and safety of pimavanserin,…
- Better Understanding of Parkinson’s Psychosis Needed to Develop New Therapies, Study Suggests May 10, 2018 Improved understanding of Parkinson’s disease psychosis (PDP) and a unified approach for its clinical evaluation are key for developing new therapeutics, a review study suggests. The research, “Treating Hallucinations and Delusions Associated With Parkinson’s Disease Psychosis,” was published in the journal Current Psychiatry Reports. PDP has been increasingly recognized as a distinct clinical symptom linked with Parkinson’s progression, dementia, and…
- Trial Investigating Pimavanserin for Dementia-Related Psychosis Stopped Early Due to Positive Findings September 12, 2019 A phase 3 trial evaluating pimavanserin (Acadia) for the treatment of dementia-related psychosis has been stopped early due to positive findings in a planned interim efficacy analysis. The HARMONY trial (N=356) was evaluating the safety and efficacy of pimavanserin, an atypical antipsychotic, in preventing a relapse of psychotic symptoms in patients with dementia-related psychosis who were stabilized after 12 weeks…
- Forbes Includes Maker of Nuplazid on List of Most Innovative Growth Companies July 27, 2017 Acadia Pharmaceuticals, the maker of Nuplazid (pimavanserin), an oral medication to treat hallucinations and delusions associated with Parkinson’s disease (PD), was ranked 11th on Forbes Magazine’s 2017 list of the “World’s Most Innovative Growth Companies.” Forbes’ ranking is based on the ‘innovation premium’ of each company and includes only industries that invest in innovative solutions. An innovation premium, according to…
- How to Bring Light to the Darker Side of Parkinson’s: A Primer on Hallucinations and Delusions and How to Manage Them July 18, 2018 When most people think of Parkinson’s, they think of the motor symptoms that often come with it: tremor, rigidity, slowness, shuffling. However, they are often unaware that Parkinson’s comes with a wide variety of non-motor symptoms that can affect thinking, mood and behavior as well. Parkinson’s disease psychosis is a non-motor symptom of Parkinson’s that causes people to experience hallucinations…
- Better Biomarkers Needed to Diagnose, Predict Risk of Mild Cognitive Impairment March 15, 2018 There still are no reliable biomarkers for early detection, or to characterize and predict risk of dementia, in Parkinson’s disease, according to a recent analysis. Several studies on the cognitive deficits, progression to dementia, potential biomarkers and the mechanisms underlying Parkinson’s disease mild cognitive impairment (PD-MCI) were analyzed by University College London researchers in the review study “Mild Cognitive Impairment in…