This month's featured products include viloxazine extended-releast capsules, lumateperone, and more.
Viloxazine Extended-Release Capsules (Qelbree)
Manufactured by Supernus Pharmaceuticals, Inc
The FDA has approved an expanded indication for viloxazine extended-release capsules (Qelbree) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults. The flexible-dose, once-daily nonstimulant drug is now approved for the treatment of children 6 years and older, and adolescents, as well as adults. This most recent FDA approval is based on data from a phase 3 trial showing that when compared to the control group, patients treated with viloxazine treated extended release capsules achieved a statistically significant greater reduction in the change from baseline in the Adult ADHD Investigator Rating Scale (AISRS) total score and an improved AISRS subscale for hyperactivity/impulsivity and inattention.
For more information: supernus.com
Manufactured by Intra-Cellular Therapies, Inc
The FDA has approved 2 new strengths for lumateperone (Caplyta), 10.5 and 21 mg, for specific patient populations. Lumateperone is a once-a-day, oral antipsychotic indicated for the treatment of schizophrenia or depressive episodes associated with bipolar I or II disorder in adults as either as a monotherapy or an adjunctive therapy with lithium or valproate. It is also being studied for the treatment of major depressive disorder and other neurological and neuropsychiatric disorders. The recommended dosage for individuals concomitantly taking moderate to strong CYP3A4 inhibitors is 10.5 mg and for individuals with moderate or severe hepatic impairment it is 21 mg. The most common adverse reactions are dizziness, dry mouth, nausea, and somnolence/sedation.
For more information: intracellulartherapies.com
Oteseconazole Capsules (Vivjoa)
Manufactured by Mycovia Pharmaceuticals, Inc
The FDA has approved oteseconazole capsules (Vivjoa) for the treatment of recurrent vulvovaginal candidiasis (RVVC), also known as chronic yeast infection, in women with a history of the condition who are not of reproductive age—making it the first FDA-approved treatment for this condition. The drug’s sustained efficacy was demonstrated through significant long-term reduction of RVVC recurrence. Its approval was based on findings from a trio of phase 3 trials, 2 global VIOLET studies and the US-focused ultraVIOLET study. In the VIOLET studies, 93.3% and 96.1%, respectively, of participants with RVVC who received the drug did not experience recurrence during the 48-week maintenance period, and in the ultraVIOLET study 89.7% of patients who received the drug cleared an initial infection and did not have a recurrence during the 50-week maintenance period.
For more information: mycovia.com
Benzoyl Peroxide Cream, 5% (Epsolay)
Manufactured by Sol-Gel Technologies, Ltd; Galderma Holding SA
Benzoyl peroxide cream, 5% (Epsolay) is now FDA-approved for the treatment of inflammatory lesions of rosacea in adults. The benzoyl peroxide is encased in silica-based patented microcapsules that slowly release it, providing a favorable efficacy and safety profile. The cream’s approval is supported by data from 2 identical phase 3 clinical trials, in which inflammatory lesions of rosacea were reduced by nearly 70% by the end of both 12-week trials in participants treated with the benzoyl peroxide cream vs a 38% to 46% reduction in those given the placebo; 50% of participants receiving the cream were deemed clear or almost clear at 12 weeks vs 38% to 46% who used the placebo. Additionally, a post hoc analysis of lesion count and investigator’s global assessment success at week 2 confirmed a significantly greater treatment effect for the benzoyl peroxide cream relative to placebo as early as week 2.
For more information: galderma.com/us