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Alkermes
plc
ALKS today announced positive preliminary topline
results from a phase 2 study of ALKS 5461, its novel drug compound for
major depressive disorder (MDD) in patients who have an inadequate
response to standard therapies for clinical depression. ALKS 5461
reflects a new approach to the treatment of MDD based on modulation of
opioid receptors in the brain and is designed as a non-addictive, oral,
once-daily medicine. Data from the study showed that ALKS 5461
significantly reduced depressive symptoms across a range of standard
measures including the study's primary outcome measure, the Hamilton
Depression Rating Scale (HAM-D17) (p=0.026), the Montgomery–Åsberg
Depression Rating Scale (MADRS) (p=0.004) and the Clinical Global
Impression – Severity Scale (CGI-S) (p=0.035).
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