Lightlake Therapeutics Joint Clinical Trial With NIDA Shows Nasal Delivery of Naloxone for Opioid Overdose to be Promising


Lightlake Therapeutics Inc. recently announced the initial findings of its clinical trial with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, supports Lightlake’s intranasal delivery of naloxone as a promising innovative treatment for opioid overdose.

Initial data from the study shows that Lightlake’s naloxone nasal spray potentially can be delivered into the blood stream at least as quickly as the injection process currently used by hospitals, first responders, and others treating opioid overdoses.

Naloxone is a medicine currently available through injection that can rapidly reverse the overdose of prescription and illicit opioids. Lightlake, in partnership with NIDA, commenced a 2-week clinical trial on September 23, 2013, designed to evaluate Lightlake’s intranasal naloxone application.

“Opioid addiction has reached epidemic levels and is affecting families across the socio-economic spectrum, and our goal of creating an easier to use, more accessible form of naloxone is closer to becoming a reality,” said Dr. Roger Crystal, CEO of Lightlake. “With the initial goal of submitting an NDA in 2014, we will meet with the FDA to discuss the results from this study. The data will also allow us to apply our novel method to a wide range of various addictions that are currently affecting millions of people on a daily basis.”
“Given our collaboration with NIDA and current understanding of the regulatory pathway with respect to our prospective opioid overdose reversal product, we anticipate incurring relatively low costs to reach an NDA submission with the FDA,” added Kevin Pollack, CFO of Lightlake. “Upon the prospective approval and launch of our product, we expect significant market demand given the growing opioid addiction epidemic and the multiple substantial advantages of our intranasal delivery of naloxone over the current injectable delivery of naloxone.”

Lightlake Therapeutics Inc., a London-based biopharmaceutical company, is using its expertise in opioid antagonists to build a platform of innovative solutions to common addictions and related disorders. The company holds patents covering the use of intranasal naloxone to treat Binge Eating Disorder (BED) as well as patents covering addiction to drugs including cocaine, amphetamine, and MDMA. For more information, visit www.lightlaketherapeutics.com.