Date: 2013-01-03
Type of
information: Results
phase: 1
Announcement: results
Company: Alkermes (Ireland)
Product: ALKS 3831 (combination of a proprietary drug molecule, ALKS 33/samidorphan and olanzapine -Zyprexa®)
Action
mechanism:
- ALKS 3831, a proprietary drug compound for the treatment of schizophrenia, is the combination of ALKS 33, a potent opioid modulator, and the established antipsychotic agent, olanzapine. Weight gain is a common and clinically relevant 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 The weight gain side effect from atypical antipsychotics may be associated with the onset or exacerbation of diabetes and dyslipidemia, which are known risk factors for cardiovascular disease and mortality.
In preclinical models, an ALKS 3831 regimen was shown to mitigate olanzapine-induced weight gain without affecting olanzapine\'s ability to demonstrate efficacy in a standard preclinical model used to assess antipsychotic activity. In another preclinical study, ALKS 3831 was shown to attenuate olanzapine-induced weight gain and abdominal adipose accretion.
Disease: schizophrenia
Therapeutic
area: Mental diseases
Country:
Trial
details:
- The multicenter, randomized, double-blind, placebo- and active-controlled study was designed to compare the mean change from baseline in body weight in 106 healthy volunteers following three weeks of once-daily, oral administration of ALKS 3831, compared to olanzapine alone or placebo.
Latest
news:
- Alkermes has announced positive topline results from a phase 1 study of its new antipsychotic candidate, ALKS 3831, a combination of a proprietary drug molecule, ALKS 33, and olanzapine, a molecule that is commercially available under the name Zyprexa®. Data from the study showed that patients administered ALKS 3831 demonstrated significantly less weight gain compared to patients taking olanzapine.
Based on the positive results of the phase 1 study, Alkermes plans to meet with the FDA and initiate a phase 2 study of ALKS 3831 in mid calendar 2013. The company expects to present comprehensive data from the phase 1 study at an upcoming medical meeting.
The phase 1, 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. ALKS 3831 was generally well tolerated in the study, and the safety and tolerability results for ALKS 3831 were similar to those observed with olanzapine alone. 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.
Is
general: Yes
