– Study to Evaluate ALKS 3831’s Efficacy, Safety and Tolerability in the Treatment of Schizophrenia and Attenuation of Olanzapine-Associated Weight Gain –
– Topline Data From 12-Week, Double-Blind Treatment Period Expected in Early 2015 –
This double-blind, olanzapine-controlled phase 2 study randomized 309
patients at multiple centers in the U.S. and
“There is a clear and compelling clinical rationale for developing an
antipsychotic with the efficacy of olanzapine and a safety profile that
addresses the negative health impact of weight gain associated with
olanzapine,” said
This study is the first of two studies in the ALKS 3831 phase 2 clinical program. The second phase 2 study was initiated in June 2014 and is designed to evaluate ALKS 3831 for the treatment of patients with schizophrenia and alcohol use. Alcohol use complicates the clinical course of more than one-third of patients with schizophrenia,2 a population that is commonly excluded from clinical trials and is often undertreated.
Phase 2 Study Design
This phase 2, double-blind, active-controlled, dose-ranging study is designed to assess the efficacy, 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 in adult patients with schizophrenia. In the study, following a one-week oral lead-in of olanzapine, patients are 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 novel, 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 the treatment of schizophrenia in patients with 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 schizophrenia3, 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 Alkermes plc
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 Alkermes plc Transition Report on Form 10-K for the fiscal period
ended Dec. 31, 2013, and in other subsequent filings made by the company
with the U.S. Securities and Exchange Commission (
1 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.
2 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.
3
Source:
Alkermes Contacts:
For Investors:
Rebecca
Peterson, +1-781-609-6378
or
For Media:
Jennifer Snyder,
+1-781-609-6166