— Clinical Data Presented at the 53rd Annual NCDEU Meeting —
In the phase 1 study, subjects who received once-daily, oral administration of ALKS 3831 for three weeks demonstrated significantly less weight gain compared to subjects taking 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 Data from the phase 1 study showed that ALKS 3831 had a safety and tolerability profile similar to that observed in the olanzapine-only treatment group.
Based on the positive results of the phase 1 study,
Study Design and Results
The phase 1, multicenter, randomized, double-blind, placebo- and active-controlled study was designed to compare the mean change from baseline in body weight following three weeks of oral administration of ALKS 3831 in a study that included 106 healthy, normal-weight male volunteers. The safety and tolerability results for ALKS 3831 were overall similar to those observed with the olanzapine-only treatment group. Healthy volunteers who received ALKS 3831 gained an average of 2.5 kg (5.5 lbs), while subjects who received olanzapine alone gained an average of 3.4 kg (7.5 lbs). The difference between the ALKS 3831 treatment group and the control group receiving olanzapine alone was statistically significant over the three-week study period (p=0.014), with a trend indicating the potential for even greater differentiation over longer study periods.
About ALKS 3831
ALKS 3831 is a proprietary investigational medicine designed as a broad spectrum treatment for schizophrenia. ALKS 3831 is comprised of ALKS 33, a novel opioid modulator that acts as a 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.
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 a phase 2 study for
ALKS 3831; 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
ZYPREXA® is a registered trademark of
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.
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