ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) has announced the submission of a supplemental new drug application (sNDA) seeking approval from the FDA for its NUPLAZID (pimavanserin) for a new indication. The company is seeking approval for its marketed drug in the treatment of delusions and hallucinations linked with dementia-related psychosis.
NUPLAZID to benefit almost 2.4 million DRP-related psychosis patients
Once approved for DRP, this will be the second indication in which NUPLAZID has been approved for. Already the drug is used in treating Parkinson’s disease psychosis related delusions and hallucinations. NUPLAZIS is the first and only treatment that the FDA has approved for this specific indication. The regulatory agency previously granted NUPLAZID Breakthrough Therapy designation for the treatment of DRP related delusions and hallucinations.
Steve Davis, the CEO of ACADIA, indicated that this is a huge milestone for the over 2.4 million in the US suffering from DRP associated delusions and hallucinations. This represents a huge unmet medical need considering currently, there is no approved treatment option for the condition. The CEO added that the company’s vital third phase HARMONY study demonstrated significant symptom reductions as well as psychosis stabilization. Equally, it showed that there was an almost three-fold reduction in the possibility of relapse in patients that continued with NUPLAZID treatment relative to the placebo group.
ACADIA based sNDA submission on HARMONY study data
The company submitted the sNDA application based on the HARMONY study data that indicated that NUPLAZID has met the primary endpoint. Interestingly the sNDA application also includes promising efficacy results from two more placebo-controlled studies that also met primary endpoints. The application includes tolerability and safety data from finished and ongoing studies representing neurodegenerative 1,500 patients. Other studies are evaluating NUPLAZID in CNS indications are currently ongoing.
NULAZID was approved in 2016 for the treatment of Parkinson’s disease-related psychosis and has recorded strong sales since then. In Q1 2020, the drug recorded sales of $90.1 million, which is a 43% YoY Increase. The expanded label is excepted to boost sales in the coming quarters.