ADX-N05: Favorable results in narcolepsy patients

A novel agent for symptoms of excessive daytime sleepiness in narcolepsy patients has shown evidence of efficacy, according to researchers who will report their results as a late-breaking abstract at Sleep 2014.

ADX-N05, a wake-promoting agent with dopaminergic and noradrenergic activity, reduced symptoms in a 12-week, placebo-controlled, double-blind study of nearly 100 patients with narcolepsy, according to Dr. Jed Black of Jazz Pharmaceuticals and Stanford (Calif.) Sleep Medicine Center, and his colleagues.

Efficacy was based on improvements at 4 and 12 weeks from baseline in average sleep-onset latency on the Maintenance of Wakefulness Test and Clinical Global Impression-Change scale. A secondary endpoint was change on the Epworth Sleepiness Scale.

For the study, 49 patients were randomized to placebo and 44 to the active drug. The active drug was initiated at 150 mg/day for 4 weeks and increased to 300 mg/day for weeks 5-12.

At week 4, average sleep-onset latency on the Maintenance of Wakefulness Test was 9.5 minutes in those on the active drug and 1.4 minutes in those on placebo, a difference that was statistically significant (P less than .0001). Improvements on the Clinical Global Impression-Change scale were 80% vs. 51%; (P = .0066), and Epworth Sleepiness Scale scores had decreased (5.6 points vs. 2.4 points; P = 0.0038).

Further improvements were noted at 12 weeks, with average sleep-onset latency on the Maintenance of Wakefulness Test of 12.8 minutes vs. 2.1 minutes; (P less than .0001). Epworth Sleepiness Scale scores were 8.5 points vs. 2.5 points (P less than .0001), and the proportion of patients with Clinical Global Impression-Change scale improvements was 86% vs. 38% (P less than .0001), according to the researchers, who will present their complete study results at the annual meeting of the Associated Professional Sleep Societies.

Adverse events were more common with the active drug and included headache, nausea, diarrhea, insomnia, decreased appetite, and anxiety. Three study subjects halted active therapy because of adverse events. Two serious events—conversion disorder and acute cholecystitis—occurred in the active treatment group and were probably unrelated to drug therapy, according to the researchers.

The study was supported by Aerial BioPharma. Dr. Black is with Jazz Pharmaceuticals, which has acquired ADX-N05 from Aerial BioPharma.

A novel agent for symptoms of excessive daytime sleepiness in narcolepsy patients has shown evidence of efficacy, according to researchers who will report their results as a late-breaking abstract at Sleep 2014.

ADX-N05, a wake-promoting agent with dopaminergic and noradrenergic activity, reduced symptoms in a 12-week, placebo-controlled, double-blind study of nearly 100 patients with narcolepsy, according to Dr. Jed Black of Jazz Pharmaceuticals and Stanford (Calif.) Sleep Medicine Center, and his colleagues.

Efficacy was based on improvements at 4 and 12 weeks from baseline in average sleep-onset latency on the Maintenance of Wakefulness Test and Clinical Global Impression-Change scale. A secondary endpoint was change on the Epworth Sleepiness Scale.

For the study, 49 patients were randomized to placebo and 44 to the active drug. The active drug was initiated at 150 mg/day for 4 weeks and increased to 300 mg/day for weeks 5-12.

At week 4, average sleep-onset latency on the Maintenance of Wakefulness Test was 9.5 minutes in those on the active drug and 1.4 minutes in those on placebo, a difference that was statistically significant (P less than .0001). Improvements on the Clinical Global Impression-Change scale were 80% vs. 51%; (P = .0066), and Epworth Sleepiness Scale scores had decreased (5.6 points vs. 2.4 points; P = 0.0038).

Further improvements were noted at 12 weeks, with average sleep-onset latency on the Maintenance of Wakefulness Test of 12.8 minutes vs. 2.1 minutes; (P less than .0001). Epworth Sleepiness Scale scores were 8.5 points vs. 2.5 points (P less than .0001), and the proportion of patients with Clinical Global Impression-Change scale improvements was 86% vs. 38% (P less than .0001), according to the researchers, who will present their complete study results at the annual meeting of the Associated Professional Sleep Societies.

Adverse events were more common with the active drug and included headache, nausea, diarrhea, insomnia, decreased appetite, and anxiety. Three study subjects halted active therapy because of adverse events. Two serious events—conversion disorder and acute cholecystitis—occurred in the active treatment group and were probably unrelated to drug therapy, according to the researchers.

The study was supported by Aerial BioPharma. Dr. Black is with Jazz Pharmaceuticals, which has acquired ADX-N05 from Aerial BioPharma.

A novel agent for symptoms of excessive daytime sleepiness in narcolepsy patients has shown evidence of efficacy, according to researchers who will report their results as a late-breaking abstract at Sleep 2014.

ADX-N05, a wake-promoting agent with dopaminergic and noradrenergic activity, reduced symptoms in a 12-week, placebo-controlled, double-blind study of nearly 100 patients with narcolepsy, according to Dr. Jed Black of Jazz Pharmaceuticals and Stanford (Calif.) Sleep Medicine Center, and his colleagues.

Efficacy was based on improvements at 4 and 12 weeks from baseline in average sleep-onset latency on the Maintenance of Wakefulness Test and Clinical Global Impression-Change scale. A secondary endpoint was change on the Epworth Sleepiness Scale.

For the study, 49 patients were randomized to placebo and 44 to the active drug. The active drug was initiated at 150 mg/day for 4 weeks and increased to 300 mg/day for weeks 5-12.

At week 4, average sleep-onset latency on the Maintenance of Wakefulness Test was 9.5 minutes in those on the active drug and 1.4 minutes in those on placebo, a difference that was statistically significant (P less than .0001). Improvements on the Clinical Global Impression-Change scale were 80% vs. 51%; (P = .0066), and Epworth Sleepiness Scale scores had decreased (5.6 points vs. 2.4 points; P = 0.0038).

Further improvements were noted at 12 weeks, with average sleep-onset latency on the Maintenance of Wakefulness Test of 12.8 minutes vs. 2.1 minutes; (P less than .0001). Epworth Sleepiness Scale scores were 8.5 points vs. 2.5 points (P less than .0001), and the proportion of patients with Clinical Global Impression-Change scale improvements was 86% vs. 38% (P less than .0001), according to the researchers, who will present their complete study results at the annual meeting of the Associated Professional Sleep Societies.

Adverse events were more common with the active drug and included headache, nausea, diarrhea, insomnia, decreased appetite, and anxiety. Three study subjects halted active therapy because of adverse events. Two serious events—conversion disorder and acute cholecystitis—occurred in the active treatment group and were probably unrelated to drug therapy, according to the researchers.

The study was supported by Aerial BioPharma. Dr. Black is with Jazz Pharmaceuticals, which has acquired ADX-N05 from Aerial BioPharma.