FDA says positives outweigh risks on Acadia’s Parkinson’s psychosis drug
pharmafile | March 30, 2016 | News story | Research and Development, Sales and Marketing | FDA, Parkinson's, Parkinsons, acadia, nuplazid, pimavanserin, psychosis
Acadia Pharmaceuticals (NASDAQ: ACAD) has announced a positive result from the US Food and Drug Administration (FDA) concerning Nuplazid (pimavanserin) for the treatment of psychosis related to Parkinson’s disease.
A panel of the FDA’s Psychopharmacologic Drugs Advisory Committee voted 12 to 2 that the benefits of Nuplazid outweighed the potential risks of treatment. The FDA has granted the new drug application for Nuplazid priority review status and has designated the drug for the treatment of psychosis associated with Parkinson’s disease as a breakthrough therapy.
The drug itself is a small molecule that is a selective serotonin inverse agonist preferentially targeting receptors that play an important role in psychosis. Approximately 40% of patients with Parkinson’s disease suffer from the related psychosis, which is characterised by hallucinations and delusions, a diminished quality of life, and significant caregiver burden.
Steve Davis, president and CEO at Acadia, comments: “We are very encouraged by the Committee’s positive vote today and look forward to working with the FDA as it completes its review of Nuplazid. If approved by the FDA, Nuplazid would be the first drug indicated to treat psychosis associated with Parkinson’s disease.”
Acadia’s drug has been highlighted as a potential blockbuster in the making. Recently, we revealed the results of a Thomson Reuters report which predicted it could achieve sales of $1.4 billion by 2020.
Sean Murray
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
