Med Check: Lybalvi and Weight Gain; Rexulti and Schizophrenia; and More

Patients in a phase 3 trial who took Lybalvi (olanzapine and samidorphan) for schizophrenia, schizophreniform disorder, or bipolar I disorder gained less weight compared with patients who took olanzapine, Alkermes announced in February. Lybalvi is approved for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder.

In the trial, 408 patients aged 16 to 39 were randomized to receive either Lybalvi or olanzapine for up to 12 weeks. The primary endpoint was change in body weight from baseline to week 12. At study’s end, those who took Lybalvi experienced a mean weight gain of 4.91% and those who took olanzapine had a mean weight gain of 6.77%. The proportion of patients who gained 10% or more of their baseline body weight at three months was 21.9% for Lybalvi, compared with 30.4% for olanzapine. The mean change from baseline in waist circumference at three months was 2.99 cm for patients who took Lybalvi compared with 3.90 cm for patients who took olanzapine.

In December the U.S. Food and Drug Administration (FDA) approved the atypical antipsychotic Rexulti (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years or older, Otsuka America Pharmaceutical Inc. announced. The approval is based on the results of a phase 3 trial of 194 adolescents aged 13 to 17 years who had schizophrenia, of which 140 took Rexulti for at least six months. Adverse events reported in this age group were generally similar to those observed in adult patients and include a rise in total cholesterol from normal to high, lowering of HDL cholesterol, and an increase in triglycerides.

The recommended starting dosage for adolescents is 0.5 mg once daily on for the first four days, taken orally with or without food, 1 mg once daily on the fifth through seventh days, then 2 mg on the eighth day, after which weekly dose increases can be made in 1 mg increments. The maximum recommended daily dosage is 4 mg.

In January the FDA approved Quviviq (daridorexant) 25 mg and 50 mg for the treatment of adults with insomnia who have trouble falling or staying asleep, Idorsia Ltd. announced. Quviviq is a dual orexin receptor antagonist and does not sedate the brain. It works by interfering with the processes through which naturally occurring orexin in the body controls wakefulness.

In a phase 3 clinical trial that included 1,854 adults with insomnia, patients were randomized to receive Quviviq (10 mg, 25 mg, or 50 mg) or placebo once daily in the evening for three months. Primary efficacy endpoints for both studies were the change from baseline to the end of the first month and third month in how long it took for patients to fall asleep and how long they stayed asleep as measured by polysomnography in a sleep laboratory. Patients also reported their total sleep time every morning at home using a validated sleep diary questionnaire.

Patients who took either 25 mg or 50 mg of Quviviq fell asleep more quickly, stayed asleep longer, and reported more total sleep at the end of the first month and third month compared with patients who took placebo. ■