FDA approves ACADIA Pharmaceuticals’ Nuplazid (pimavanserin)
![](/46/pdcnewsitem/04/03/22/acadia.png)
The first drug approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
ACADIA Pharmaceuticals has announced that the 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.
“Today’s approval of Nuplazid represents a major paradigm shift in the treatment of Parkinson’s disease psychosis,” said Michael S. Okun, 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.
“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 CEO. “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, CEO 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.”
Related News
-
News Global advancements in the diagnosis and treatment of rare diseases: Rare Disease Day 2024
Rare Diseases Day is celebrated on the 29th February 2024 and represents the plight of rare disease patients to gain diagnosis and access to suitable treatment. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance