– Study Will Evaluate ALKS 3831’s Safety, Tolerability and Effect on the Attenuation of Weight Gain Associated With Olanzapine –
“We have designed ALKS 3831 as a broad spectrum schizophrenia agent
addressing two specific patient subpopulations: patients who may benefit
from attenuation of the significant weight gain often associated with
olanzapine treatment; and patients with a dual diagnosis of substance
abuse disorder, which often exacerbates their schizophrenia,” said
The ALKS 3831 comprehensive phase 2 clinical program is comprised of two separate studies, including the study announced today focused on the attenuation of weight gain associated with olanzapine. Weight gain is a common and clinically relevant metabolic side effect of atypical antipsychotic medications, and olanzapine has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs.1 The second phase 2 study will investigate the potential utility of ALKS 3831 for the large number of patients with the dual diagnosis of schizophrenia and substance abuse disorder, a group representing as many as 50% of patients with schizophrenia.2
Phase 2 Study Design
The phase 2, double-blind, active-controlled, dose-ranging study is
designed to assess the safety and tolerability of ALKS 3831, as well as
evaluate the impact of ALKS 3831 on weight and other metabolic factors
in comparison to olanzapine alone in approximately 400 adult patients
with schizophrenia. In the study, following a one-week oral lead-in of
olanzapine, patients will be randomly assigned to olanzapine or three
different doses of ALKS 3831 for a period of 12 weeks, followed by a
12-week period in which all patients will receive ALKS 3831.
About ALKS 3831
ALKS 3831 is a proprietary investigational medicine designed as a broad spectrum treatment for schizophrenia. ALKS 3831 is composed of ALKS 33, a novel potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine. ALKS 3831 is designed to attenuate olanzapine-induced metabolic side effects, including weight gain, and to have utility in patients with schizophrenia and comorbid substance abuse disorder.
About Schizophrenia
Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million Americans have schizophrenia, with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness.
About
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including, but not limited to
statements concerning: the therapeutic value of ALKS 3831 and clinical
development plans for ALKS 3831. You are cautioned that forward-looking
statements are inherently uncertain. Although the company believes that
such statements are based on reasonable assumptions within the bounds of
its knowledge of its business and operations, the forward-looking
statements are neither promises nor guarantees and they are necessarily
subject to a high degree of uncertainty and risk. Actual performance and
results may differ materially from those projected or suggested in the
forward-looking statements due to various risks and uncertainties. These
risks and uncertainties include, among others: whether preclinical and
clinical results for ALKS 3831 will be predictive of future clinical
study results; whether the company will initiate studies for ALKS 3831
for dual-diagnosis patients; whether future clinical trials for ALKS
3831 will be completed on time or at all; potential changes in cost,
scope and duration of the ALKS 3831 clinical development program;
whether ALKS 3831 could be shown ineffective or unsafe during clinical
studies; and those risks described in the
1Komossa K, Rummel-Kluge C, Hunger H, Schmid F, Schwarz S, Duggan L, Kissling W, Leucht S. Olanzapine versus other atypical antipsychotics for schizophrenia. Cochrane Database of Systematic Reviews. 2010, Issue 3. Art. No.: CD006654.
2Koola M, Wehring H, Kelly D. The Potential Role of
Long-acting Injectable Antipsychotics in People with Schizophrenia and
Comorbid Substance Use.
Source:
Alkermes:
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Rebecca
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or
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Jennifer Snyder,
+1-781-609-6166