FDA Breakthrough designation for ACADIA's Nuplazid for Parkinson's disease psychosis

US biotech firm ACADIA Pharmaceuticals (Nasdaq: ACAD) says that the US Food and Drug Administration has granted Breakthrough Therapy designation to Nuplazid (pimavanserin) for the treatment of Parkinson’s disease psychosis. The company’s shares leapt 11% to $26.61 in after-hours trading on Tuesday.

Nuplazid is a selective serotonin inverse agonist and, if approved, will establish a new and distinctly different pharmacological approach to treating psychosis, according to the US firm. Nuplazid has successfully completed a pivotal Phase III trial in Parkinson’s disease psychosis, which the FDA has agreed can serve as the basis, together with supportive data from other studies, for a New Drug Application. ACADIA plans to submit the Nuplazid NDA to the FDA near the end of this year.

“The hallucinations and delusions in Parkinson’s disease psychosis are devastating to patients and contribute to a dramatic rise in caregiver burden,” said Joyce Oberdorf, president and chief executive of the National Parkinson Foundation. “Parkinson’s disease psychosis is a leading cause of nursing home placement for Parkinson’s patients and, with no FDA-approved therapy for this serious condition, there is a great unmet medical need for an effective, safe, and well-tolerated treatment option for patients,” she added.