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–– Designed to Assess Weight Gain Profile of Olanzapine Compared to ALKS 3831 in Patients Diagnosed With Schizophrenia, Schizophreniform or Bipolar I Disorder Who Are Early in Their Illness ––
–– Supportive Study in the
“First-episode schizophrenia is a critical phase of the disease where
optimal antipsychotic efficacy is crucial to reduce the rate of relapse
and potentially improve long-term outcomes. Olanzapine is well-known to
be a highly efficacious atypical antipsychotic treatment but is no
longer recommended first-line for early-in-illness patients due to its
metabolic liabilities,1” said
“With a novel pharmacologic approach designed with the real-world needs
of patients in mind, we believe that ALKS 3831 has the potential to have
a meaningful impact on the treatment of schizophrenia, particularly in
this young adult population that has demonstrated susceptibility to
antipsychotic weight gain and who could benefit from a highly effective
medicine early in the course of their disease,” stated Richard Pops,
Chief Executive Officer of
ENLIGHTEN-Early is a 12-week, multicenter, randomized, double-blind, phase 3 study comparing the weight gain profile of ALKS 3831 to olanzapine in approximately 250 young adults with schizophrenia, schizophreniform disorder or bipolar I disorder who are early in their illness. 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 24 months. The objective of the extension phase of the study is to assess the long-term safety, tolerability and durability of effect of once-daily, oral ALKS 3831.
About the ENLIGHTEN Clinical Development Program
The ENLIGHTEN clinical development program for ALKS 3831 is comprised of two key studies: a study evaluating the antipsychotic efficacy of ALKS 3831 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, the effect on body weight of ALKS 3831 in young adult patients early in their illness, and long-term safety.
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.2 ALKS 3831 is designed to provide the strong antipsychotic efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.
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.
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 to serve as the basis for an NDA 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 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 1 metabolic study and the ENLIGHTEN pivotal trials for ALKS 3831 will be completed on time or at all; whether the results of the phase 1 metabolic study will show favorable metabolic effects of ALKS 3831 compared to olanzapine; 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 and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended
ZYPREXA® is a registered trademark of Eli Lilly & Company.
1The 2009 Schizophrenia PORT Psychopharmacological Treatment
Recommendations and Summary Statements. Schizophrenia
Bulletin. 2010, Vol. 36
2Komossa, K. et al. Olanzapine versus other atypical antipsychotics for schizophrenia. Cochrane Database of Systematic Reviews. 2010, Issue 3. Art. No.: CD006654.
Eva Stroynowski, +1 781-609-6823
Sandy Coombs, +1 781-609-6377
Jennifer Snyder, +1 781-609-6166