Lightlake Therapeutics Announces Phase II Clinical Trial Results of Treatment for Binge Eating Disor
Mar 27th 2013 6:49AM
Updated Mar 27th 2013 6:52AM
Lightlake Therapeutics Announces Phase II Clinical Trial Results of Treatment for Binge Eating Disorder Accepted at the American Psychiatric Association Annual Meeting
LONDON--(BUSINESS WIRE)-- Lightlake Therapeutics Inc. ( OTCBB: LLTP) (the "Company" or "Lightlake"), an early stage biopharmaceutical company developing addiction treatments, announced today that a scientific abstract based on results of the Company's Phase II clinical trial of its opioid antagonist nasal spray treatment for patients with Binge Eating Disorder (BED) has been accepted for presentation at the American Psychiatric Association Annual Meeting taking place in San Francisco, California, May 18-22, 2013.
The abstract, entitled "Opioid antagonist naloxone nasal spray treatment for patients with Binge Eating Disorder (BED): Controlled Randomized Study, will be presented by Professor Hannu Alho, MD, professor of addiction medicine at the University of Helsinki and Principal Investigator for the trial.
Dr. Roger Crystal, Chief Executive Officer of Lightlake, commented, "We are pleased that our Phase II study was accepted by this most prestigious medical organization. We believe intranasal naloxone is a truly differentiated treatment for BED, one of the major causes of obesity and the most chronic and common of all eating disorders, because it extinguishes the harmful eating behavior."
About the Trial
The randomized, double-blind, placebo-controlled Phase II study assessed the efficacy, safety and tolerability of intranasal naloxone in 127 adults who met DSM-IV-TR® criteria for a diagnosis of binge eating disorder. The study duration was 24-weeks. Patients were randomized to intranasal naloxone (2 mg before each binge, max daily 4 mg) or placebo nasal spray. The two co-primary efficacy endpoints were the mean minutes spent binge eating and the mean scores on the standard Binge Eating Scale (BES). Overall, 81% of patients completed the entire six month study, and there were no Serious Adverse Events (SAE).
Patients in the naloxone group showed a statistically significant 75.2% reduction in binge eating. The trial EudraCT registry # is 2010-019892-31 and is also registered at ClinicalTrials.gov. The study was sponsored by Lightlake Therapeutics Inc.
Naloxone an opioid antagonist that blocks the brain's opioid receptors for a short length of time. It is not an appetite suppressant, nor does it prevent the body from absorbing fat, but rather deals with the physiological and psychological underpinnings that cause cravings for foods high in fat, salt or sugar. Intranasal naloxone is absorbed within minutes, and over time, results in the extinction of the harmful eating behavior. Naloxone exerts its effects over two hours, which is the typical duration of a binge, and is unlikely to extinguish other healthy behaviors such as the desire to exercise. This treatment is geared towards eliminating a harmful eating behavior that can lead to serious health problems and enabling people with BED to re-regain control over their eating habits.
About Lightlake Therapeutics Inc.
Lightlake Therapeutics Inc. is a developing biopharmaceutical company using its expertise in opioid antagonists to build a platform of innovative pharmaceutical solutions to common addictions and related disorders. The Company's current focus is the development of a simple, safe, and effective treatment for patients who are obese or overweight as a result of Binge Eating Disorder, as well as those patients suffering from Bulimia Nervosa. Lightlake recently acquired patents that will allow expansion of its product pipeline to address treatment for addiction to opioid painkillers, methadone, cocaine and amphetamine. The Company anticipates launching a development program for each of these purposes in the future.
Forward Looking Statement
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," estimates," "predicts," "projects," "potential" or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward- looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this presentation to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
Lightlake Therapeutics Inc.
Dr. Roger Crystal, +44(0)203 617 8739
Chief Executive Officer
Porter, LeVay & Rose, Inc.
Michael J. Porter, 212-564-4700
KEYWORDS: United Kingdom United States Europe North America California
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