Merck Provides Update on Phase III Clinical Program for Preladenant, the Company’s Investigational Parkinson’s Disease Medicine
May 23, 2013 4:00 pm ET
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today provided an update on the clinical program for preladenant,
Merck’s investigational adenosine A2A receptor antagonist for
the treatment of Parkinson’s disease (PD). An initial review of data
from three separate Phase III trials did not provide evidence of
efficacy for preladenant compared with placebo.
Based on these results, Merck is taking steps to discontinue the
extension phases of these studies and no longer plans to pursue
regulatory filings for preladenant. The decision to discontinue these
studies is not based on any safety finding. The results of these studies
will be presented at an upcoming scientific meeting and will be
submitted for publication in a peer-reviewed journal.
“While these results are disappointing, this program is an important
example of Merck’s continued commitment to pursue promising science with
the goal of bringing forward medicines that address important unmet
medical needs,” said David Michelson, M.D., vice president, clinical
research, Neuroscience and Ophthalmology at Merck Research Laboratories.
“Parkinson’s disease is very complex, making it difficult to treat
patients and develop novel therapeutic approaches. We are committed to
neuroscience research and will be conducting further analyses of the
data to inform the scientific community’s efforts in finding new
approaches to treat this debilitating disease. We thank the
investigators and importantly the Parkinson’s patients who participated
in the preladenant clinical program.”
The Phase III clinical program for preladenant included three
randomized, controlled clinical trials to evaluate safety and efficacy.
Two of these studies assessed preladenant when added to levodopa therapy
in patients with moderate-to-severe PD, and one assessed preladenant as
monotherapy in early PD. More information about the preladenant Phase
III clinical trials is available on www.clinicaltrials.gov.
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