– Study Will Evaluate Efficacy, Safety and Tolerability of ALKS 3831 in Patients With Schizophrenia Whose Symptoms Are Exacerbated by Alcohol Use Disorder –
“Schizophrenia is a very challenging disease to treat and is frequently
complicated by alcohol use, which can exacerbate symptoms and is
associated with poor long-term outcomes,” said
This study is the second in the ALKS 3831 comprehensive phase 2 clinical
program; the first phase 2 study was initiated in
Phase 2 Study Design
This phase 2, randomized, double-blind, active-controlled study is
designed to assess the efficacy, safety and tolerability of ALKS 3831 in
adult patients with schizophrenia and co-occurring alcohol use disorder
over a treatment period of up to 15 months. Approximately 450 patients
will be enrolled in the study. The objective of this study is to compare
symptom exacerbation between the two treatment groups.
About ALKS 3831
ALKS 3831 is a proprietary investigational medicine designed as a broad-spectrum antipsychotic for the treatment of schizophrenia. ALKS 3831 is composed of samidorphan (formerly referred to as 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 whose disease is exacerbated by alcohol use.
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 American adults 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, as amended, including, but not
limited to statements concerning: the therapeutic value of ALKS 3831 and
clinical development plans for ALKS 3831. The company cautions 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 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
1 Regier D, Farmer M, Rae D, Locke B, Keith S, Judd L, Goodwin F. Comorbidity of Mental Disorders With Alcohol and Other Drug Abuse. JAMA. 1990, 264: 2511-2518.
2 Komossa 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.
Source:
Alkermes:
For Investors:
Rebecca
Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder,
+1 781-609-6166