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Dasotraline effective for binge-eating disorder, not ADHD in adults
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Sunovion Pharmaceuticals recently announced dasotraline, a dopamine and norepinephrine reuptake inhibitor, met its primary efficacy endpoint for moderate-to-severe binge-eating disorder in adults, but did not meet its primary endpoint for ADHD in adults.
“We are pleased to see such strong results in our first major study of dasotraline in patients with binge-eating disorder,” Antony Loebel, MD, executive vice president and chief medical officer of Sunovion, said in a press release. “We remain confident in the potential for dasotraline to offer a new, differentiated therapeutic option for adults with [binge-eating disorder] as well as children and adults with ADHD. We look forward to sharing the results of our ongoing clinical studies.”
To assess efficacy of dasotraline for binge-eating disorder, researchers conducted a phase 2/3, 12-week, randomized, double-blind, parallel-group, multicenter, placebo-controlled, flexible-dose study among adults aged 18 to 55 years with moderate-to-severe binge-eating disorder. Study participants received 4 mg to 8 mg of dasotraline or placebo once-daily.
At 12 weeks, analysis indicated statistically significant improvement in number of binge days per week among participants who received dasotraline vs. those who received placebo.
Further, study participants who received dasotraline exhibited statistically significant improvements in Clinical Global Impression of Severity Illness Scale (CGI-S) scores, the Yale Brown Obsessive Compulsive Scale Modified for Binge-Eating scores and percentage of individuals who abstained from binge eating for 4 weeks.
To assess efficacy for ADHD in adults, researchers conducted a phase 3, eight-week, randomized, double-blind, multicenter, placebo-controlled, fixed-dose study among adults aged 18 to 55 years with ADHD. Participants received 4 mg or 6 mg of dasotraline or placebo once-daily.
At 8 weeks, study participants who received dasotraline did not exhibit statistically significant improvements on total ADHD Rating Scale IV scores, compared with placebo.
However, researchers found a trend toward greater improvement among participants who received 6 mg of dasotraline (P = .074), compared with placebo.
Participants who received 6 mg of dasotraline exhibited statistically significant improvement on the CGI-S at study endpoint.
Study participants who received placebo exhibited relatively large improvement on the ADHD Rating Scale IV, which researchers suggest may have affected primary endpoint findings.
Sunovion plans to release full study results for these disorders at upcoming scientific meetings and submit a New Drug Application depending on successful completion of ongoing studies, according to the release.