Biopharmaceutical company Alkermes has reported positive results from a Phase I study of ALKS 3831, which evaluated the orally-administered drug candidate as a broad spectrum treatment for schizophrenia.
ALKS 3831 comprises a novel opioid modulator, ALKS 33, and antipsychotic drug olanzapine, which is commercially available as Zyprexa.
Alkermes chief medical officer Dr Elliot Ehrich said that combining the opioid-modulating properties of ALKS 33 with olanzapine provides the possibility for a wider spectrum of schizophrenia, as the drug has two marked benefits for patients and physicians.
"First, we believe that ALKS 3831 has the potential to attenuate the clinically significant weight gain commonly seen with olanzapine, and diminishing this side effect could open its proven therapeutic benefits to a wider range of patients with schizophrenia," Ehrich said.
"Second, we see potential applicability for the large number of patients with the dual diagnosis of schizophrenia and substance abuse – a group representing as many as half of patients with schizophrenia."
Designed to compare the mean change from baseline in body weight subsequent to three-week oral administration of ALKS 3831, the double-blind, placebo and active-controlled study included 106 healthy male volunteers with normal weight.
Subjects orally-administered with ALKS 3831 once each day for a period of three weeks in the multicentre, randomised study showed considerably less weight gain compared to those administered with olanzapine.
ALKS 3831 showed a safety and tolerability profile that was similar to olanzapine.
The company expects to commence a Phase II dose-ranging study of ALKS 3831 in schizophrenia later this year to assess its safety and effect on metabolic outcomes such as weight gain.
Image: Schizophrenic Brain. Photo: Courtesy of The National Institutes of Health.