BioCentury
ARTICLE | Clinical News

Pimavanserin: Additional Phase III data

March 25, 2013 7:00 AM UTC

Additional data from the double-blind, North American Phase III ACP-103-020 trial in 199 patients with PDP showed that once-daily 40 mg oral pimavanserin met the secondary endpoints of improving CGI-S scores (p<0.001) and CGI-I responder analyses vs. placebo (p=0.002). Specifically, the CGI-I responder analyses showed that about twice as many patients in the pimavanserin arm were rated as "very much improved" or "much improved" at the end of the study vs. placebo. Pimavanserin also led to significant improvements in scores on the SAPS 20-item scale and in each of the separate hallucinations and delusions domains vs. placebo. Patients received placebo or once-daily 40 mg oral pimavanserin as an adjunct to stable doses of their existing anti-Parkinson's therapy following a 2-week screening period that included brief psycho-social therapy. Patients who completed the trial were eligible to enroll in an open-label safety extension study. Data were presented at the American Academy of Neurology meeting in San Diego.

Acadia previously reported that pimavanserin met the primary endpoint of improving antipsychotic efficacy as measured by the mean reduction from baseline to day 43 in scores on the SAPS-PD 9-item scale vs. placebo (5.79 vs. 2.73 points, p=0.001). Pimavanserin also met the secondary endpoint of non-inferiority to placebo in maintaining motoric tolerability as measured by Parts II and III of the UPDRS from baseline to day 43. Additionally, pimavanserin met the secondary endpoint of improving CGI-I scores vs. placebo (p=0.001) (see BioCentury, Dec. 3, 2012). ...