The multicenter, randomised, double-blind phase 3 study will evaluate the weight gain profile of ALKS 3831 compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, in patients with stable schizophrenia over a six-month treatment period.
The ENLIGHTEN clinical development programme 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, and long-term safety.
ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet. ALKS 3831 is designed to provide the strong antipsychotic efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.
Alkermes is developing innovative medicines for the treatment of central nervous system diseases.
The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. The company is headquartered in Dublin, Ireland, with an R and D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
GC Biopharma's GC1130A receives EMA Orphan Drug Designation
Guangzhou Fermion Technology's FZ008-145 IND application receives Chinese regulatory approval
Newron enrols 290 patients in schizophrenia study
Vistagen granted European patent for AV-101 to treat neuropathic pain
Alora Pharmaceuticals announces Relexxii commercial launch
IGC Pharma granted patent for Alzheimer's drug formulation
NRx Pharmaceuticals signs data agreement with Columbia University for IV Ketamine trials
Cambridge Cognition launches AQUA for automated quality assurance in CNS clinical trials
Shanghai Zhimeng Biopharma's CB03 receives US FDA orphan drug designation
Genentech's Alecensa demonstrates 76% reduction in disease recurrence risk
NRx Pharmaceuticals announces presentation at 8th Annual Dawson James Conference