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–– ENLIGHTEN-2 Will Evaluate Weight Gain Profile of Novel,
“There is a clear and compelling clinical rationale for developing an
antipsychotic with the efficacy of olanzapine and a safety profile that
addresses the substantial negative health impact of weight gain and
metabolic consequences associated with olanzapine,” said
ENLIGHTEN-2 is a multicenter, randomized, double-blind phase 3 study comparing weight gain of ALKS 3831 to olanzapine in approximately 540 patients with stable schizophrenia over six months. Safety and tolerability will also be evaluated in the study. All participants in the double-blind portion of the study will be eligible to continue in an open-label safety study of ALKS 3831 for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term tolerability of once-daily, oral ALKS 3831.
About the ENLIGHTEN Clinical Program
The ENLIGHTEN pivotal program for ALKS 3831 is comprised of two key
studies: a study evaluating ALKS 3831’s antipsychotic efficacy compared
to placebo over four weeks and a study assessing weight gain with ALKS
3831 compared to olanzapine in patients with schizophrenia over six
months. The program also includes supportive studies to evaluate the
pharmacokinetic and metabolic profile of ALKS 3831, as well as long-term
Further information about the ENLIGHTEN studies can be found at www.clinicaltrials.gov.
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, a novel, new molecular entity co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
Weight gain is a common and clinically relevant metabolic side effect of atypical antipsychotic medications, and olanzapine, commercially available as ZYPREXA®, has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs.1 ALKS 3831 is designed to provide the strong efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.
ALKS 3831 is also being evaluated for the treatment of schizophrenia in
patients with co-occurring alcohol use disorder. A phase 2 study,
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,3 with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia, which is one of the most serious types of mental illness.
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, development
plans and commercial potential of ALKS 3831; and the adequacy of the
ENLIGHTEN pivotal program for ALKS 3831 to serve as the basis for an
NDA. 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 expressed or implied 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 ongoing phase 2 trial and the ENLIGHTEN pivotal
trials for ALKS 3831 will be initiated or 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
ZYPREXA® is a registered trademark of Eli Lilly & Company.
1Komossa, K. et al. Olanzapine versus other atypical antipsychotics for schizophrenia. Cochrane Database of Systematic Reviews. 2010, Issue 3. Art. No.: CD006654.
2Regier, D. et al. Comorbidity of Mental Disorders With Alcohol and Other Drug Abuse. JAMA. 1990, 264: 2511-2518.
Eva Stroynowski, +1-781-609-6823
Jennifer Snyder, +1-781-609-6166