Phase III data released for NUPLAZID (pimavanserin) for Parkinson's disease psychosis

ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, have announced the presentation of integrated efficacy and tolerability data from its Phase III program with NUPLAZID™ (pimavanserin) at the 19th International Congress of Parkinson's Disease and Movement Disorders held in San Diego.

"Data from the integrated analysis of Phase III studies continue to support the potential for NUPLAZID to safely and effectively treat Parkinson's disease psychosis, a condition for which there is no approved therapy in the United States," said Roger Mills, M.D., Executive Vice President, Development and Chief Medical Officer. "Furthermore, data from our open-label safety extension studies indicate that long-term administration of NUPLAZID is generally safe and well tolerated in patients with Parkinson's disease psychosis and that duration of antipsychotic effect may be maintained for longer than the six weeks investigated in our Phase III placebo-controlled efficacy studies."

Poster Presentations

Efficacy and Tolerability of NUPLAZID™ (pimavanserin) in PD Psychosis: Analysis of an Integrated Phase 3 Placebo-Controlled Dataset (Abstract #156)

An integrated analysis was performed on efficacy and tolerability data from two six-week Phase III placebo-controlled clinical trials with NUPLAZID (40 mg) in Parkinson's disease psychosis (PDP). In this large pooled sample of 268 patients from North America, NUPLAZID showed highly significant improvement in psychosis compared to placebo on the 9-item SAPS-PD scale (p<0.001). NUPLAZID demonstrated significant improvement on each of the separate hallucinations and delusions domains and also on secondary psychoses measures, including the Clinical Global Impression-Improvement (CGI-I) and the Clinical Global Impression-Severity (CGI-S) scales. In addition, NUPLAZID demonstrated significant improvement on nighttime sleep, daytime wakefulness and caregiver burden, representing additional potential clinically impactful benefits. Results were consistent across all subgroups of interest, showing greater improvement with NUPLAZID over placebo regardless of age, sex, race group or MMSE screening score.

Pooled analysis of data from all Phase III placebo-controlled clinical trials with NUPLAZID showed that NUPLAZID was well tolerated and had no impairment on motor function. The adverse event profile of NUPLAZID was similar to placebo.

Long-Term Effectiveness of NUPLAZID™ (pimavanserin) in PD Psychosis: Data from 2 Open-Label Studies (Abstract #149)

Data from two open-label safety extension studies were presented, including final data from a completed Phase II open-label study (-010 Study) of 39 PDP patients and interim data from an ongoing Phase III open-label study (-015 Study) of 459 PDP patients. The interim analysis of the ongoing -015 Study reflects data entered into the database as of December 13, 2013. PDP patients in the -015 Study rolled in after completing 6 weeks of blinded treatment in a Phase III placebo-controlled efficacy, tolerability and safety trial. PDP patients in the -010 Study rolled in following completion of the 4-week treatment period in a Phase II placebo-controlled efficacy, tolerability and safety trial. In both open-label studies, patients remained on treatment for a median duration of over 15 months.

Data from the two open-label studies suggest that long-term administration of NUPLAZID is generally safe and well tolerated in patients with PDP. Although there are no formal efficacy endpoints in the open-label studies, persistent antipsychotic benefit has been observed in one or both studies across measures including SAPS-PD, other SAPS-based outcomes, CGI-I and CGI-S. In the -015 Study, patients who rolled in from a placebo arm showed a highly significant improvement in SAPS-PD and CGI-S scores at Week 4 compared to their score at the end of the 6-week randomized study. This improvement was observed for the combined U.S. and rest-of-world patients. Persistent benefit on caregiver burden with NUPLAZID has also been observed.

About NUPLAZID™ (pimavanserin)

NUPLAZID is ACADIA's proprietary small molecule that is a selective serotonin inverse agonist preferentially targeting 5-HT2A receptors that play an important role in psychosis. ACADIA has reported positive Phase III trial results with NUPLAZID, which has the potential to be the first drug approved in the United States for psychosis associated with Parkinson's disease. NUPLAZID is administered orally once-a-day. ACADIA discovered NUPLAZID and holds worldwide rights to this new chemical entity. The trade name NUPLAZID has been provisionally accepted by the FDA.

About Parkinson's Disease Psychosis

According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson's disease. Parkinson's disease psychosis (PDP) is a debilitating disorder that occurs in an estimated 40 percent of Parkinson's patients. Currently, there is no FDA-approved therapy to treat PDP in the United States. PDP, which commonly consists of visual hallucinations and delusions, substantially contributes to the burden of Parkinson's disease and deeply affects the quality of life of patients. PDP also is associated with increased caregiver stress and burden, nursing home placement, and increased morbidity and mortality. There is a large unmet medical need for new therapies that will effectively treat PDP without compromising motor control in patients with Parkinson's disease.