Lightlake Therapeutics has provided additional details of recently announced Phase 2 trials of its naloxone nasal spray for binge eating disorder and for bulimia nervosa.
Binge eating disorder trials have begun in Helsinki, with 138 patients randomly selected from more than 900 applicants taking either intranasal naloxone or a placebo nasal spray, says the company. Finnish research organization Crown CRO is providing validation, and the trial coordinator is Hannu Eero Rafael Alho, Professor of Addiction Medicine at the University of Helsinki. Lightlake says that it has agreements with Lloyds Pharmacy and Celesio regarding the nasal spray.
The company says that it still plans to begin Phase 2 trials for bulimia nervosa in 2012, with Professor Janet Treasure, head of the Eating Disorders Unit at the South London and Maudsley NHS Trust, and Professor Ulrike Schmidt, a consultant psychiatrist for the Eating Disorders Service and a fellow of the Academy for Eating Disorders as “prospective guides for these trials.”
Lightlake also provided additional information about its expectations for the trial outcomes. Among other things, the new press release asserts that the company “expects the nasal spray is unlikely to be used in a truly chronic manner—patients would only administer the treatment when they have the urge to binge eat, and would require less of the spray over time as they regain control of their eating habits.” The binge eating trial is also evaluating the nasal spray’s ability to reinforce an exercise program and its effects in patients with the A118G genotype.
Read the Lightlake press release.