HAMILTON, N.J. and ROCKVILLE, Md., Oct. 26 /PRNewswire/ —
MedAvante, Inc., the leader in centralized expert evaluation of
central nervous system (CNS) disorders, and Rexahn Pharmaceuticals,
Inc. (NYSE Amex:
RNN) a clinical stage pharmaceutical company developing and
commercializing potential best in class oncology and CNS
therapeutics, announced that Rexahn will use MedAvante ‘s Remote
Centralized Ratings™ in their randomized, double-blind,
placebo-controlled Phase 2b clinical study assessing the efficacy
of Serdaxin® in patients with major depressive disorder (MDD).
MedAvante’s centralized ratings were chosen to reduce bias
and variability associated with CNS trials.
Rexahn is the latest in a growing number of pharmaceutical
companies deciding to use centralized raters, who are free of study
biases, for CNS trials. This approach has empirically demonstrated
the ability to reduce rater variability and the placebo effect.
Centralized assessments in other therapeutic areas, including
oncology, imaging and cardiovascular, are used to reduce bias and
minimize variability and have been described affirmatively in
regulatory guidance documents. Now centralized calibrated
raters conducting real-time psychiatric assessments are achieving
the same benefits for sponsors of CNS studies.
Rexahn’s Serdaxin is a well characterized chemical entity tested
for multiple CNS indications. Data from a Phase 2a study in
MDD has shown that Serdaxin has the potential to improve symptoms
of depression, without the side effects commonly associated with
currently marketed antidepressants.
“As a company seeking to develop and deliver new treatments for
CNS disorders, it is vital that we design and conduct clinical
trials that maximize rater objectivity and standardization,” said
Rick Soni, President and Chief Operating Officer of Rexahn.