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Saturday, 05/18/2019 1:26:28 PM

Saturday, May 18, 2019 1:26:28 PM

Post# of 251306
Acad to present Ph 2 results on Tuesday of Pimavanserin in MDD. They look quite good to me. Ph 3 initiated last month. Is the FDA approval process likely to be more streamlined to add MDD to the label for an already approved drug? ... or it makes no difference?


ACADIA Pharmaceuticals to Present Phase 2 CLARITY Results for Pimavanserin as an Adjunctive Treatment in Major Depressive Disorder at the 2019 American Psychiatric Association Annual Meeting

Poster PresentationPoster:
#P8-049Date/Time: Tuesday, May 21, 2:00 p.m. - 4:00 p.m. Pacific
TimeTitle: CLARITY: A Phase 2 Double-blind, Placebo-controlled
Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in
Major Depressive Disorder


The Phase 2 CLARITY study was a 10-week, randomized, double-blind,
placebo-controlled, multi-center, two-stage sequential parallel
comparison design study that evaluated the efficacy, safety, and
tolerability of pimavanserin (34 mg once daily). Pimavanserin was
administered as an adjunctive treatment in patients with MDD who had an
inadequate response to a stable dose of standard antidepressant therapy
with either a selective serotonin reuptake inhibitor (SSRI) or a
serotonin norepinephrine reuptake inhibitor (SNRI). The study randomized
207 patients across 27 clinical research centers in the U.S

In the trial, pimavanserin met the overall primary endpoint of the
weighted average results of Stage 1 and Stage 2 by significantly
reducing the 17-item Hamilton Depression Rating Scale total score
compared to placebo (p=0.039). On the key secondary endpoint,
pimavanserin demonstrated statistically significant reductions compared
to placebo in the Sheehan Disability Scale score (p=0.004). Positive
results were also observed for seven other secondary endpoints,
including improvement in daytime sleepiness as measured by the
Karolinska Sleepiness Scale and improvement in sexual function as
measured by the Massachusetts General Hospital Sexual Functioning Index.


"In this Phase 2 study of pimavanserin as an adjunctive treatment for
MDD, we found patients treated with pimavanserin experienced significant
reduction in their depression symptoms in addition to improvement in
daytime sleepiness and sexual function when compared to placebo," said
Serge Stankovic, M.D., M.S.P.H., ACADIA's President. "These results are
encouraging for patients with MDD who may experience challenges with
their current treatment options. We look forward to further evaluating
pimavanserin as an adjunctive treatment in our ongoing Phase 3 CLARITY
program."

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