FDA Drug Approvals, Psychiatry — 2021 Midyear Review

August 20, 2021

Lybalvi (olanzapine/samidorphan)

Olanzapine/samidorphan is indicated for treatment of schizophrenia in adults. It is also approved for bipolar I disorder as monotherapy or as an adjunct to lithium or valproate. Olanzapine acts through a combination of dopamine and serotonin type 2 antagonism. Samidorphan is an opioid antagonist and mitigates weight gain associated with olanzapine.

Approval was based on the ENLIGHTEN clinical trials. Olanzapine is associated with metabolic changes. including hyperglycemia, dyslipidemia, and weight gain. The ENLIGHTEN trials showed the combination provided sustained antipsychotic efficacy with minimal effects on weight, waist circumference, and metabolic parameters. Am J Psychiatry. 2020 Dec 1;177(12):1168-1178

Azstarys (serdexmethylphenidate/dexmethylphenidate)

Serdexmethylphenidate/dexmethylphenidate is a fixed-dose combination of the prodrug of dexmethylphenidate, serdexmethylphenidate, and immediate-release dexmethylphenidate. This combination provides extended drug levels. It is indicated for attention deficit hyperactivity disorder in adults and children aged 6 years and older. Efficacy was assessed by Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP)–combined scores compared with baseline and at 0.5, 1, 2, 4, 8, 10, 12, and 13 hours post dose. Results showed statistically significant improvement of SKAMP-combined scores compared with placebo. Azstarys prescribing information

Qelbree (viloxazine)

Viloxazine is indicated for treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6-17 years. The mechanism of action by which viloxazine affects ADHD is unclear; however, it may be by selectively inhibiting norepinephrine reuptake. Approval was based on 3 phase-3 placebo-controlled trials that included over 1000 participants. Patients taking viloxazine had statistically significant improvement in ADHD Rating Scale 5 and Clinical Global Impressions I scores compared with placebo. Qelbree prescribing information

Other psychiatry approval

Kloxxado (naloxone intranasal) - New formulation that delivers 8 mg per actuation, compared with older products that deliver 2 mg or 4 mg per actuation.


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