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ACADIA Pharmaceuticals Announces FDA Priority Review of NUPLAZID™ (Pimavanserin) New Drug Application for Parkinson’s Disease Psychosis
PDUFA Date Set for May 1, 2016

SAN DIEGO--(BUSINESS WIRE)--Nov. 2, 2015-- ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced that the New Drug Application (NDA) for NUPLAZID™ (pimavanserin) has been accepted for review by the U.S. Food and Drug Administration (FDA) and the agency has granted it Priority Review. ACADIA is seeking FDA approval of NUPLAZID for the treatment of psychosis associated with Parkinson’s disease. The FDA granted NUPLAZID Breakthrough Therapy designation for this indication in 2014.

The FDA grants Priority Review to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. Priority Review accelerates the review timeline from 10 months to six months from the date of acceptance of filing. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of May 1, 2016.

“The FDA Priority Review designation underscores the potential for NUPLAZID to provide an important treatment to patients with Parkinson’s disease psychosis, a condition for which there is no FDA-approved therapy,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “We look forward to working with the FDA during the review.”

NUPLAZID is a new class of non-dopaminergic antipsychotic that acts as an SSIA (selective serotonin inverse agonist), preferentially targeting 5-HT2A receptors. Through this novel mechanism, NUPLAZID has demonstrated significant efficacy in Parkinson’s disease psychosis.

According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. An estimated 40 percent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions, a diminished quality of life, and significant caregiver burden.

ACADIA’s NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of NUPLAZID for Parkinson’s disease psychosis. The NDA includes data from the pivotal Phase III -020 Study, in which NUPLAZID showed statistical improvement on all primary and secondary efficacy endpoints with no worsening of motor function. Detailed results of the -020 Study were published in The Lancet.
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Source: press release, 11/02/15. http://news.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&I...

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ACADIA Pharmaceuticals Submits New Drug Application for NUPLAZID™ for the Treatment of Parkinson’s Disease Psychosis

SAN DIEGO--(BUSINESS WIRE)--Sep. 3, 2015-- ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease.

NUPLAZID is an SSIA (selective serotonin inverse agonist) preferentially targeting 5-HT2A receptors. Through this novel mechanism, NUPLAZID has demonstrated significant efficacy in Parkinson’s disease psychosis (PDP) and has the potential to avoid many of the debilitating side effects of existing antipsychotics, none of which are approved for use in PDP patients. The FDA granted NUPLAZID Breakthrough Therapy designation for PDP in 2014.

“NUPLAZID holds promise for patients with Parkinson’s disease psychosis who currently have no FDA-approved treatment options,” said Steve Davis, ACADIA’s Chief Executive Officer. “Psychosis is the leading cause for Parkinson’s patients moving from their homes to nursing homes or other institutions and leads to an increased risk of mortality, a diminished quality of life and significant caregiver burden. If approved, NUPLAZID would represent a new and distinctly different pharmacological approach to treating psychosis and would be the first drug approved in the United States for psychosis associated with Parkinson’s disease.”

According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. An estimated 40 percent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions. Currently, there is no FDA-approved therapy to treat Parkinson’s disease psychosis.

ACADIA’s NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of NUPLAZID for Parkinson’s disease psychosis. The NDA includes data from the pivotal Phase III -020 Study, in which NUPLAZID met all primary and secondary endpoints with statistical significance, along with supportive data from other studies with NUPLAZID. The -020 Study demonstrated that NUPLAZID significantly reduced psychosis compared to placebo in patients with Parkinson’s disease psychosis with no worsening of motor function. These results were further supported by significant improvements in all secondary efficacy measures and by significant benefits in exploratory efficacy measures of nighttime sleep, daytime wakefulness and caregiver burden. Consistent with previous studies, NUPLAZID was safe and well tolerated in the -020 Study. Detailed results of the -020 Study have been published in The Lancet.

ACADIA has requested a Priority Review of its NDA. If granted, Priority Review status would accelerate the review timeline from ten months to six months following the conclusion of the 60 calendar day filing review period that begins on the FDA’s receipt of the NDA. The FDA informs the applicant of a Standard or Priority Review designation following the conclusion of this 60 calendar day period.

Separately, ACADIA issued a news release today announcing that its Board of Directors has appointed Steve Davis as Chief Executive Officer.
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Source: press release, 9/03/15. http://news.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&I...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Nuplazid (Pimavanserin) (ACP-103) Parkinson’s disease psychosis (PDP)NeurologyParkinson’s disease psychosis (PDP)5-HT2A receptor inverse agonist5-HT2A receptor

Mechanism of action: Nuplazid (Pimavanserin) (ACP-103), a SM-inverse agonist, demonstrates anti psychotic effects via a potent and selective 5-HT2A inverse agonist mechanism of activity.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-05-01

Results:

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FDA Approves ACADIA Pharmaceuticals’ NUPLAZID™ (pimavanserin) - The First Drug Approved for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis
U.S. Commercial Launch Planned for June 2016

An Estimated 40 Percent of Parkinson’s Disease Patients Have Psychosis

Conference Call Scheduled on Monday, May 2 at 8:30 a.m. ET

SAN DIEGO--(BUSINESS WIRE)--Apr. 29, 2016-- ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. In 2014, the FDA designated NUPLAZID as a Breakthrough Therapy for this condition.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160429006144/en/

NUPLAZID™ (pimavanserin) bottle (Photo: Business Wire)
NUPLAZID™ (pimavanserin) bottle (Photo: Business Wire)

“Today’s approval of NUPLAZID represents a major paradigm shift in the treatment of Parkinson’s disease psychosis,” said Michael S. Okun, M.D., Medical Director of The National Parkinson Foundation. “Through its novel and selective mechanism of action, NUPLAZID is a breakthrough treatment that works in a whole new way - treating hallucinations and delusions without blocking dopamine receptors and, therefore, not impairing motor function in Parkinson’s psychosis patients.”

NUPLAZID is the first and only medicine to be approved by the FDA for this indication. NUPLAZID is also the only drug approved by the FDA that preferentially targets 5-HT2A receptors. These receptors are thought to play an important role in Parkinson’s disease psychosis. The unique pharmacology of NUPLAZID establishes a new class of drug - selective serotonin inverse agonists (SSIA) - by not only preferentially targeting 5-HT2A receptors but also avoiding activity at dopamine and other receptors commonly targeted by antipsychotics. Typical Parkinson’s disease therapy consists of drugs that stimulate dopamine to treat patients’ motor symptoms such as tremor, muscle rigidity and difficulty with walking. NUPLAZID does not interfere with patients’ dopaminergic therapy and therefore does not impair their motor function.

According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. An estimated 40 percent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions, is associated with significant caregiver burden, and is a major reason for nursing home placement among Parkinson’s patients.

“NUPLAZID represents a major medical advancement for patients with Parkinson’s disease psychosis who suffer from hallucinations and delusions,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “We are grateful to the many patients and investigators who participated in NUPLAZID’s clinical studies. NUPLAZID represents the culmination of many years of work across our entire organization to bring this novel medicine, discovered by our scientists, to patients in need.”

“Parkinson’s disease psychosis is a debilitating condition that adds a tremendous burden on the lives of patients already contending with motor issues such as slow movement, loss of balance, and muscle rigidity,” said Todd Sherer, Ph.D., Chief Executive Officer of the Michael J. Fox Foundation. “It also places an increased burden on caregivers and can lead to loss of independence and nursing home admittance for patients. A therapy to treat the hallucinations and delusions associated with Parkinson’s disease psychosis without worsening motor symptoms can significantly impact the lives of Parkinson’s patients and their loved ones.”
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Source: press release, 4/29/16. http://news.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&I...

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