Med Check: Zavegepant; Quviviq; Qelbree; and More

FDA Reviews Zavegepant for Migraine

In May Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new drug application for zavegepant nasal spray for the acute treatment of migraine in adults.

A previous phase 3 trial of 1,269 patients who had at least a one-year history of migraine with or without aura showed that those who took intranasal zavegepant experienced greater relief of migraine pain compared with those who took placebo. Patients in the trial were randomized to take a single 10 mg dose of zavegepant or placebo when they experienced a migraine attack.

Twenty-four percent of patients who took zavegepant reported being free of pain two hours after taking their dose compared with 15% of patients who took placebo. In addition, 40% of patients who took zavegepant reported freedom from their most bothersome symptom at two hours compared with 31% of those who took placebo.

Quviviq Available for Adults With Insomnia

Idorsia’s insomnia drug Quviviq (daridorexant) is now available, the company announced in May. It is indicated for the treatment of adults with insomnia that is characterized by difficulties falling or staying asleep.

In a phase 3 trial, 930 patients with insomnia received either 25 mg or 50 mg of Quviviq or placebo once nightly for three months. Compared with patients who took placebo, those who took either dose of Quviviq fell asleep faster and experienced improved sleep maintenance as measured by polysomnography in a sleep lab and as recorded in patient diaries. Quviviq 50 mg also significantly improved daytime functioning.

In a second phase 3 trial, 924 adults with insomnia received either 10 mg or 25 mg of Quviviq or placebo once in the evening for three months. Compared with patients who took placebo, those who took 25 mg of Quviviq experienced significantly improved sleep maintenance as measured by polysomnography in a sleep lab and as recorded in patient diaries. The results were statistically significant at the end of the first month and at the end of the third month.

Qelbree Approved for Adults With ADHD

In April the FDA approved Qelbree (viloxazine extended-release) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults, Supernus Pharmaceuticals announced. The drug was previously approved for ADHD in pediatric patients aged 6 to 17 years. Qelbree is not a stimulant and is not a controlled substance.

In a phase 3 trial, adults aged 18 to 65 years who had ADHD received a flexible daily dose of Qelbree between 200 mg and 600 mg or placebo for six weeks. At the end of six weeks, those who took Qelbree experienced a 15.5-point decrease on the ADHD Investigator Symptom Rating Scale total score, whereas those who took placebo experienced a decrease of 11.7 points. Those who took Qelbree also had greater improvements on the Clinical Global Impression–Severity of Illness Scale compared with those who took placebo.

Qelbree has a boxed warning regarding the risk of suicidal thoughts and behavior. The drug may increase suicidal thoughts and actions in children and adults with ADHD, especially in the first few months of treatment or when the dose is changed. Before starting treatment, patients should be screened for a personal or family history of suicide, bipolar disorder, and depression. ■