, May 3, 2012
/PRNewswire/ -- Lightlake Therapeutics Inc. (OTCBB: LLTP) (the "Company" or "Lightlake"), an early stage biopharmaceutical company developing addiction treatments, announced today very encouraging preliminary results in the Phase II clinical trial of the Company's opioid antagonist nasal spray treatment for patients with Binge Eating Disorder (BED). BED is a psychiatric condition that is manifested by recurrent episodes of eating unusually large amounts of food in a short period of time associated with a sense of lack of control.
Lightlake's randomised, double-blind, placebo-controlled, six month Phase II clinical trial enrolling 127 subjects in Helsinki for the treatment of binge eating disorder (BED) with intranasal naloxone has been completed successfully. There were no serious adverse events and 81% of patients completed the entire 6 months with no statistically significant difference in dropout rates between the placebo and the treatment groups.
The primary endpoint was measured as the time (minutes) per week spent binge eating. The group receiving naloxone showed a highly significant (p<0.001) reduction in their time spent binge eating. The trial was designed to provide the best treatment to both groups except that only the naloxone group received the active medication. Consequently, the placebo group also reduced their time spent binge eating. The reduction for the naloxone group, however, was significantly (p=0.024) greater than that for the placebo group. The reduction in the final week was 56% greater with naloxone (158 min) than with placebo (101 min).
The reduction in bingeing showed the same pattern across time (called an "extinction curve") as has been previously reported for the treatment of alcohol dependence with similar opioid antagonists. The behavior shows little change during the first few weeks of treatment, but the effect becomes progressively greater month after month. "We are pleased that the data showed that there is an 'extinction curve' where the benefits of the drug therapy improved over time," commented Dr. David Sinclair, Chief Scientific Officer, Lightlake Therapeutics. "We know from our earlier research that permitting people to engage in their problematic behaviour here binge eating while at the same time receiving drug therapy, results in the person losing interest in that behaviour, essentially 'extinguishing' binge eating."
The other primary endpoint was measuring the improvement on a standard questionnaire concerning how subjects felt about their binge eating in the previous month (Binge Eating Scale, BES). Both groups showed highly significant improvement during the trial, however there was no significant improvement of the naloxone group over placebo.
The naloxone treatment is not directly an obesity drug, but it does eventually remove the binge eating behavior that can produce obesity. Whilst weight loss was not a primary outcome measure, it was observed that during the first half of the trial (weeks 1 to 12), while binge eating was still frequent, as expected, the BMI (body mass index) continued to increase for both the placebo and naloxone groups, but during the second half of the trial (weeks 13 to 24), when binge eating was greatly reduced, the naloxone group (but not the placebo group) showed a statistically significant (p=0.039) reduction in BMI.
"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," said Dr Roger Crystal, M.D, CEO of Lightlake Therapeutics Inc. "Lightlake is committed to research that can help us advance our treatment of BED and other addictive behaviours 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."
Dr. David Sinclair PhD, developer of the extinction method for treating addictions, stated, "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."
About Binge Eating Disorder
The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR®) research criteria for binge eating disorder, as set forth in Appendix B (Criteria Sets and Axes Provided for Further Study), defines Binge Eating Disorder by:
1. Recurrent episodes of binge eating characterized by BOTH of the following:
a. Eating in a discrete amount of time (within a 2 hour period), an amount that is definitely larger than most people would eat during a similar time period.
b. Sense of lack of control over eating during an episode.
2. Binge eating episodes are associated with three (or more) of the following:
a. Eating much more rapidly than normal.
b. Eating until uncomfortably full.
c. Eating large amounts of food when not hungry.
d. Eating alone because of being embarrassed by how much one is eating.
e. Feeling disgust with oneself, depressed, or guilty after overeating.
3. Marked distress regarding binge eating is present.
4. The binge eating occurs, on average, at least 2 days a week for 6 months.
5. The binge eating is not associated with the regular use of inappropriate compensatory behaviors (e.g. purging, fasting, compulsive exercising).
ABOUT THE STUDY
This Phase 2, randomized, double-blind, placebo-controlled, study assessed the efficacy, safety and tolerability of intranasal naloxone in 127 adults aged 20 years to 72 years (mean 46 years) 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)or placebo nasal spray.
Patients with concurrent symptoms of bulimia nervosa or anorexia nervosa and/or other current severe psychiatric disorders were excluded from the study. Patients were excluded from the study for pregnancy and/or breast-feeding, for drug dependence (particularly opiates) or alcohol dependence (based on the initial interview, (measured with AUDIT: Alcohol Use Disorders Identification Test), had untreated psychiatric illness (based on the initial anamnesis), serious depression or risk of suicide (measured by the BDI: Beck Depression Inventory, a BDI score of more than 25), or were individuals meeting the definitions provided in Sections 7 to 10 of the (Finnish) Medical Research Act, i.e., pregnant women, incapacitated persons, and prisoners. Naloxone was statistically superior to placebo on the primary end point of bingeing reduction but not on the BES (binge eating scale). The reduction in binge eating was measured by the self- reported minutes of bingeing per week. The reduction was calculated from an average baseline from the first 3 weeks of the study (consistent with other opioid antagonist extinction studies) to the second half of study.
The study also evaluated the safety and tolerability of naloxone based on occurrence of treatment-emergent adverse events (TEAEs), vital signs, BMI and clinical laboratory results.
There were no serious adverse events (SAEs), and evaluation of side effects is underway.
Possible known side-effects of naloxone include: change in mood, increased sweating, nausea, nervousness, restlessness, trembling, vomiting, allergic reactions such as rash or swelling, dizziness, fainting, fast or irregular pulse, flushing, headache, heart rhythm changes, seizures, sudden chest pain.
Lightlake is still evaluating the safety information related to discontinuation rates, vital signs, and clinical laboratory results, which will help inform the design of future larger studies.
The Principal Investigator for the trial is Hannu Alho, professor of addiction medicine at the University of Helsinki. Crown CRO, a Finnish Contract Research Organization provided support to the trial.
About Lightlake Therapeutics, Inc.
Lightlake Therapeutics Inc. is a developing biopharmaceutical company aiming to build a platform of biopharmaceutical solutions to common addictions and related disorders. Currently, the Company is focused developing a treatment for patients suffering from Binge Eating Disorder and patients suffering from Bulimia Nervosa. Lightlake also aims to address patients with addictions to opioid painkillers, methadone, cocaine, and amphetamine. The Company anticipates launching a development program for each of these purposes in the future.
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.
Mr. Kevin Fickle, President
NUWA Group LLC
Dr. Roger Crystal
Lightlake Therapeutics Inc.
SOURCE Lightlake Therapeutics Inc.