The potential new treatment has demonstrated reduced weight gain in patients with schizophrenia compared to olanzapine.
Unexpected weight gain linked to antipsychotics is one of the leading reasons schizophrenia treatment adherence rates can be low.
Recently, investigators from Alkermes announced positive data testing a combination of olanzapine and samidorphan (ALKS 3831) in schizophrenia patients, specifically evaluating the weight gain profile of the medication.
The ENLIGHTEN-2 was a six-month study evaluating the weight gain profile of ALKS 3831 compared to olanzapine in 561 patients with stable schizophrenia. ALKS 3831 is an investigational, novel atypical antipsychotic earmarked for once-daily oral application for the 2 psychiatric disorders composed of samidorphan, a novel, new molecular entity, co-formulated with olanzapine, an established antipsychotic agent in a single bilayer tablet.
In an interview with HCPLive®, Adam Simmons, MPH, Director of Clinical Program Management, Alkermes, explained how important it is for treatment options to reduce some of the side effects that can often lead to adherence issues for schizophrenia patients.
Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder. There is a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15.