Clinical Trials Resource Center

Binge Eating Disorder

August 20, 2012

Lightlake Therapeutics reported results from a phase II trial of intranasal naloxone for the treatment of Binge Eating Disorder (BED). This randomized, double-blind, placebo-controlled, six-month study enrolled 127 patients in Helsinki, Finland. Subjects receiving the naloxone nasal spray achieved the study’s primary endpoint by exhibiting a statistically significant reduction in time spent per week binge eating (125 minutes/week reduction) compared to those patients who received a placebo nasal spray (84 minutes/week reduction) (p=0.024). During the last week of treatment, naloxon-treated patients reduced their bingeing by 158 minutes/week compared to 101 minutes/week for placebo-treated subjects (p=0.018). Patients with a BMI>35 (considered severely obese) had particularly impressive results: naloxon-treated patients reduced their bingeing by 210.8 minutes/week compared to 83.8 minutes/week for the placebo-treated patients during the last week of the trial (p=0.004). The nasal spray was well tolerated. Adverse events were the same in both the placebo and naloxon groups. Lightlake Therapeutics did not note its plans for intranasal naloxone, but said longer use of the nasal spray would produce even better results.

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