“Among Parkinson’s patients, psychosis causes great distress for
patients and caregivers and is the leading cause of
institutionalization,” said
Pimavanserin met the primary endpoint in the -020 Study by demonstrating highly significant improvement in psychosis compared to placebo on the 9-item SAPS-PD scale (p=0.001), which was assessed by central, independent raters. The mean change in SAPS-PD score represented a 37% improvement for pimavanserin versus 14% for placebo (p<0.001). Pimavanserin also demonstrated significant improvement on the full 20-item SAPS (hallucinations plus delusions) measure (p=0.001) and on each of the separate hallucinations and delusions domains in supportive analyses.
Significant improvements were observed for pimavanserin over placebo on additional investigator-assessed secondary measures of psychosis benefit, including the Clinical Global Impression Severity, or CGI-S, scale (p<0.001), and the Clinical Global Impression Improvement, or CGI-I, scale (p=0.001). The proportion of CGI-I responders was also higher for pimavanserin versus placebo, (49% vs. 26%, p=0.002). Pimavanserin met the key secondary endpoint for motoric tolerability as measured using Parts II and III of the Unified Parkinson’s Disease Rating Scale, or UPDRS. Caregivers in the pimavanserin group also reported significant reduction in caregiver burden (p=0.002), and participants reported significant improvements on nighttime sleep (p=0.045) and daytime wakefulness (p=0.012) for pimavanserin over placebo in exploratory analyses.
Consistent with previous studies, pimavanserin was well tolerated in the -020 Study with no significant safety concerns or impairment in motor function. The most common treatment-emergent adverse events were urinary tract infection (13.5% PIM vs. 11.7% PBO) and falls (10.6% PIM vs. 8.5% PBO). Although adverse event discontinuations were higher in the pimavanserin group compared to placebo, overall drop-outs in the -020 Study were low compared to other reported studies in PDP and similar neuropsychiatric conditions.
“The -020 Study results presented in The Lancet suggest that
pimavanserin has the potential to provide a safe, well-tolerated, and
effective alternative to existing antipsychotic drugs. Current atypical
antipsychotics are often used off-label to treat PDP despite increasing
evidence that they are associated with serious safety issues and are
poorly tolerated in this fragile and elderly patient population,” said
Phase III -020 Study Design
The pivotal Phase III trial, referred to as the -020 Study, was a
multi-center, double-blind, placebo-controlled study designed to
evaluate the efficacy, tolerability and safety of pimavanserin as a
treatment for patients with Parkinson’s disease psychosis. A total of
199 patients were enrolled in the study and randomized on a one-to-one
basis to receive either 40 mg of pimavanserin or placebo once-daily for
six weeks, following a two-week screening period including brief
psycho-social therapy. Patients also received stable doses of their
existing anti-Parkinson’s therapy throughout the study. The primary
endpoint of the -020 Study was antipsychotic efficacy as measured using
the “SAPS–PD” scale, which consists of nine items from the
hallucinations and delusions domains of the Scale for the Assessment of
Positive Symptoms (SAPS). Additional secondary and supportive measures
of efficacy were measured using the Clinical Global Impression Severity
(CGI-S) scale, the Clinical Global Impression Improvement (CGI-I) scale,
and the full 20-item SAPS. Exploratory measures of nighttime sleep,
daytime wakefulness, and caregiver burden were measured using the Scales
for Outcome in Parkinson’s Disease - Nighttime Sleep (SCOPA-NS), the
Scales for Outcome in Parkinson’s Disease - Daytime Sleep (SCOPA-DS),
and the Caregiver Burden Scale (
About Pimavanserin
Pimavanserin is ACADIA’s proprietary small molecule that acts
selectively as an antagonist/inverse agonist on serotonin 5-HT2A receptors.
ACADIA has successfully completed a pivotal Phase III trial with
pimavanserin for Parkinson’s disease psychosis (PDP), potentially
positioning it to be the first drug approved in
About Parkinson’s Disease Psychosis
According to the National Parkinson’s Foundation, about one million
people in
About
ACADIA is a biopharmaceutical company focused on innovative treatments
that address unmet medical needs in neurological and related central
nervous system disorders. ACADIA has a pipeline of product candidates
led by pimavanserin, which is in Phase III development as a potential
first-in-class treatment for Parkinson's disease psychosis. ACADIA also
has clinical-stage programs for chronic pain and glaucoma in
collaboration with
Forward-Looking Statements
Statements in this press release that are not strictly historical in
nature are forward-looking statements. These statements include but are
not limited to statements related to the progress and timing of ACADIA’s
drug discovery and development programs, either alone or with a partner,
including clinical trials, the benefits to be derived from ACADIA’s
product candidates, in each case including pimavanserin, the potential
for pimavanserin to be approved for PDP or be an important new treatment
option for PDP sufferers, and the potential of pimavanserin to provide a
safe, well-tolerated, and effective alternative to existing
antipsychotic drugs. These statements are only predictions based on
current information and expectations and involve a number of risks and
uncertainties. Actual events or results may differ materially from those
projected in any of such statements due to various factors, including
the risks and uncertainties inherent in drug discovery, development and
commercialization, and collaborations with others, and the fact that
past results of clinical trials may not be indicative of future trial
results. For a discussion of these and other factors, please refer to
ACADIA’s annual report on Form 10-K for the year ended December 31, 2012
as well as ACADIA’s subsequent filings with the
Source:
ACADIA Pharmaceuticals Inc.
Uli Hacksell, Ph.D., Chief Executive
Officer
Lisa Barthelemy, Director, Investor Relations
(858)
558-2871