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Dasotraline improves binge-eating disorder in adults

SAN DIEGO — Dasotraline, a dopamine and norepinephrine reuptake inhibitor, significantly decreased binge-eating days per week and was well-tolerated among adults with binge-eating disorder, according to data presented at the American Psychiatric Association Annual Meeting.

“Binge-eating disorder is the most common eating disorder in adults in the United States and has the potential for serious, long-term health implications if left untreated,” Susan L. McElroy, MD, chief research officer at Lindner Center of HOPE, and professor of psychiatry and behavioral neuroscience at the University of Cincinnati, said in a press release. “Continued study of [binge-eating disorder] is important, as effective treatment options which are well tolerated are needed for those living with this condition.”

To assess efficacy and safety of dasotraline for binge-eating disorder in adults aged 18 to 55 years, researchers conducted a phase 2/3, 12-week, randomized, double-blind, parallel-group, multi-center, placebo-controlled, flexible-dose study among 317 adults with moderate-to-severe binge-eating disorder. Participants received dasotraline in flexibly dosed once-daily doses ranging from 4 mg to 8 mg or placebo.

From baseline to week 12, number of binge-eating days per week improved among participants receiving dasotraline, with an effect size of 0.74 (P < .0001).

Antony Loebel, MD
Antony Loebel

Change in Clinical Global Impression of Severity Illness Scale (CGI-S) and Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) scores also statistically significantly improved among participants receiving dasotraline from baseline to week 12.

Participants who received dasotraline exhibited an effect size of 0.95 on CGI-S and 0.96 on Y-BOCS-BE (P < .0001).

Approximately 46.5% of participants who received dasotraline achieved at least 4 consecutive weeks of binge-eating cessation, compared with 20.6% of the placebo group (P < .0001).

Dasotraline was well-tolerated, according to researchers. The most common treatment-emergent adverse events, reported in 5% or more of participants, included insomnia, dry mouth, decreased appetite, anxiety, nausea, headache, decreased weight, dizziness, irritability, diarrhea, dyspepsia, constipation and thirst.

“We are encouraged by these results suggesting that dasotraline may offer a novel, well-tolerated and efficacious treatment for binge-eating disorder,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in the release. “Limited treatment options are available for this challenging illness, and there is a substantial need for additional well-tolerated and effective therapies.” – by Amanda Oldt

Reference:

Navia B, et al. Dasotraline for the treatment of moderate to severe binge eating disorder in adults: Results from a randomized, double-blind, placebo-controlled study. Presented at: American Psychiatric Association Annual Meeting; May 20-24, 2017; San Diego.

Disclosure: Navia reports financial ties with DiaMentis, Shire, Sunovion Pharmaceuticals Inc.

SAN DIEGO — Dasotraline, a dopamine and norepinephrine reuptake inhibitor, significantly decreased binge-eating days per week and was well-tolerated among adults with binge-eating disorder, according to data presented at the American Psychiatric Association Annual Meeting.

“Binge-eating disorder is the most common eating disorder in adults in the United States and has the potential for serious, long-term health implications if left untreated,” Susan L. McElroy, MD, chief research officer at Lindner Center of HOPE, and professor of psychiatry and behavioral neuroscience at the University of Cincinnati, said in a press release. “Continued study of [binge-eating disorder] is important, as effective treatment options which are well tolerated are needed for those living with this condition.”

To assess efficacy and safety of dasotraline for binge-eating disorder in adults aged 18 to 55 years, researchers conducted a phase 2/3, 12-week, randomized, double-blind, parallel-group, multi-center, placebo-controlled, flexible-dose study among 317 adults with moderate-to-severe binge-eating disorder. Participants received dasotraline in flexibly dosed once-daily doses ranging from 4 mg to 8 mg or placebo.

From baseline to week 12, number of binge-eating days per week improved among participants receiving dasotraline, with an effect size of 0.74 (P < .0001).

Antony Loebel, MD
Antony Loebel

Change in Clinical Global Impression of Severity Illness Scale (CGI-S) and Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) scores also statistically significantly improved among participants receiving dasotraline from baseline to week 12.

Participants who received dasotraline exhibited an effect size of 0.95 on CGI-S and 0.96 on Y-BOCS-BE (P < .0001).

Approximately 46.5% of participants who received dasotraline achieved at least 4 consecutive weeks of binge-eating cessation, compared with 20.6% of the placebo group (P < .0001).

Dasotraline was well-tolerated, according to researchers. The most common treatment-emergent adverse events, reported in 5% or more of participants, included insomnia, dry mouth, decreased appetite, anxiety, nausea, headache, decreased weight, dizziness, irritability, diarrhea, dyspepsia, constipation and thirst.

“We are encouraged by these results suggesting that dasotraline may offer a novel, well-tolerated and efficacious treatment for binge-eating disorder,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in the release. “Limited treatment options are available for this challenging illness, and there is a substantial need for additional well-tolerated and effective therapies.” – by Amanda Oldt

Reference:

Navia B, et al. Dasotraline for the treatment of moderate to severe binge eating disorder in adults: Results from a randomized, double-blind, placebo-controlled study. Presented at: American Psychiatric Association Annual Meeting; May 20-24, 2017; San Diego.

Disclosure: Navia reports financial ties with DiaMentis, Shire, Sunovion Pharmaceuticals Inc.

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