Lightlake Therapeutics has announced preliminary results from a Phase 2 trial of its intranasal naloxone for the treatment of patients with binge eating disorder. According to the company, the randomized, double-blind, placebo-controlled trial demonstrated that patients using the naloxone nasal spray spent a significantly smaller amount of time binge eating than did patients treated with a placebo nasal spray. In the final week of the 6-month trial, patients receiving naloxone reduced their time binge eating by 158 minutes compared to 101 minutes for placebo.
In the later portion of the trial, the naloxone group also showed a significant reduction in body mass index (BMI) due to the reduction in food intake compared to the placebo group. No serious adverse events were recorded.
Naloxone treatment results in an improvement pattern called an “extinction curve,” the company says, in which patients exhibit only minor changes in behavior during the initial weeks of treatment with progressively greater improvement after a number of months. “We are pleased that the data showed that there is an ‘extinction curve’ – where the benefits of the drug therapy improved over time. We know from our earlier research that permitting people to engage in their problematic behavior – here binge eating – while at the same time receiving drug therapy, results in the person losing interest in that behavior, essentially ‘extinguishing’ binge eating,” said Lightlake Chief Scientific Officer David Sinclair.
Sinclair added, “The improvement shown by the binge eaters given naloxone in this trial is similar to what we have seen repeatedly in the treatment of alcoholism. The magnitude of the effect and also the rate at which it develops are just about the same as with alcoholism. This supports our contention that binge eating is an addiction and can be treated successfully with a method shown to work with other addictions. Moreover, it can be done with a single medicine having a long record of safe usage.”
Lightlake CEO Roger Crystal commented, “We are very pleased with the preliminary results of this study, and we will continue to conduct further evaluation on the additional data captured in the study. Lightlake is committed to research that can help us advance our treatment of BED and other addictive behaviors – disorders that affect millions of individuals worldwide. The data from this study provides further evidence that naloxone may also be a promising treatment for Bulimia Nervosa, which is another related disease that is covered in our patent portfolio. We will work closely with regulatory authorities, to launch further studies to confirm naloxone as a suitable treatment for Binge Eating Disorder.”
Read the Lightlake press release.
