ACADIA Pharmaceuticals Inc.ACAD

ACADIA Pharmaceuticals Inc. focuses on psychiatry. The company's drug, Nuplazid (pimavanserin), received approval on April 29, 2016. The recommended dose for Nuplazid is 34 mg, or 10 mg when administered with strong CYP3A4 inhibitors. The pimavanserin program for PDP was granted Breakthrough status. Pimavanserin is classified as an Atypical antipsychotic (Serotonin receptor 2A (5-HT2A) inverse agonist). There are currently no FDA approved drug-treatments for PDP.

In clinical trials, Nuplazid demonstrated an improvement in psychotic symptoms over placebo (SAPS-PD) of 23.1% in ACP 103-020. The mean baseline UPDRS Parts II+III score for the placebo group in ACP-103-020 was 52.6. The risk for serious adverse events including death (SAE) for pimavanserin 34mg versus placebo was 2.38, with 3.5% of subjects on placebo experiencing SAEs. Mortality in the clozapine open label phase was 10%, and deaths in the long-term PDP open-label treatment population were 11.1%. The risk difference for irritability (All PIM vs Placebo) was -0.2%, and for PIM 34mg vs Placebo was -0.4%. Irritability incidence was 0.3%, 0.0%, and 0.4% in various observations.

Several studies were conducted, including Study -006 with 60 patients enrolled, Study -008 with 412 patients, Study -010 with 38 patients and a longest single treatment duration of >8 years, Study -012 with 287 patients and a 6-week treatment duration, Study -014 with 123 patients and a 6-week treatment duration, and Study -015 with 456 patients enrolled, 108 patients ongoing, and a longest single treatment duration of 67.5 months. Study -020 had a 6-week treatment duration. In ACP-103-020, a total of 185 subjects were randomized. The median SAPS-PD change for much improvement (CGI-I=2) was 7 points, and for minimal improvement (CGI-I=3) was a 3-point change. 44.2% of placebo arm patients had a >= 3-point change in SAPS-PD total score.