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ALKSAlkermes, Inc. (stock symbol)
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ALKS 9070 Is Designed to Offer Best-in-Class, Extended-Release, Once-Monthly Version of Aripiprazole --
ALKS 33 was designed to provide minimally metabolized, highly potent, and sublingually bioavailable mu antagonism to allow for effective coformulation of the two agents.
DUBLIN -- Alkermes plc (NASDAQ: ALKS) today announced positive topline results from a phase 1 study of its new antipsychotic candidate, ALKS 3831, a combination of a proprietary drug molecule, ALKS 33, and olanzapine, a molecule that is commercially available under the name ZYPREXA([R]).
Indeed, ALKS 5461 may represent a new rapid-onset treatment approach for depression and other psychiatric disorders, such as addictive disorder, he said.
The randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of ALKS 33, administered orally on a daily basis, versus placebo.
We had predetermined the product profile we needed to observe in order to continue to advance ALKS 37 into phase 3 clinical studies.
In the phase 1/2 clinical study, ALKS 5461 was shown to significantly reduce depressive symptoms, as measured by the Hamilton Depression Rating Scale (HAM-D17; a standard, clinician-assessed measure of depression severity), in patients with MDD who received ALKS 5461 for the seven-day treatment period.
DUBLIN -- Alkermes plc (NASDAQ: ALKS) today announced positive topline results from a phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression.
Based on the results of this study, we will focus our future clinical development efforts on the other ALKS 33 development programs, including ALKS 5461 for TRD and cocaine addiction and ALKS 33 for alcohol dependence, as well as our other promising pipeline candidates including ALKS 9070 for schizophrenia and ALKS 37 for opioid-induced constipation.
We are extremely encouraged by these positive results for ALKS 9070 as a potential treatment for schizophrenia.
The combination of ALKS 33 with buprenorphine to create ALKS 5461 leverages our expertise with opioid modulators and may create a non-addictive therapy for treatment-resistant depression.
These positive results show that ALKS 37 offers potential as a treatment for opioid-induced constipation, a serious and debilitating side effect of chronic prescription opioid therapy," said Dr.