NEW YORK, Feb. 17, 2015 /PRNewswire/ -- Lightlake Therapeutics Inc. ("Lightlake") (OTCQB: LLTP), a biopharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, announced today that Adapt Pharma Limited, Lightlake's partner for treating opioid overdose with intranasal naloxone, has received Fast Track designation by the United States Food and Drug Administration ("FDA").
Under the FDA Modernization Act of 1997, the Fast Track program was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA during clinical development and for the possibility of priority review, which can reduce the time required for FDA review of a New Drug Application.
In December 2014, Lightlake commenced a clinical trial in partnership with the National Institute on Drug Abuse ("NIDA"), a part of the National Institutes of Health ("NIH"). The new intranasal delivery system for the delivery of naloxone tested in this trial may prevent opioid overdose deaths, a public health problem of epidemic proportions in the U.S. According to the Centers for Disease Control and Prevention ("CDC"), 16,651 people died from prescription opioid overdose in the U.S. in 2010, a dramatic increase from the 4,030 overdose deaths in 1999.
"We are very pleased the FDA granted Fast Track designation to Adapt Pharma for the intranasal naloxone treatment to reverse opioid overdose," stated Dr. Roger Crystal, CEO of Lightlake. He added, "The decision reflects the critical need for better delivery of and access to naloxone. Too many lives have been lost by opioid overdose and we look forward to this novel technology being available to patients and bystanders in the U.S. We are very pleased that the team at Adapt is pushing this product forward on all fronts."
In December 2014, Lightlake announced a licensing deal with a subsidiary of Adapt Pharma Limited. In exchange for licensing its opioid overdose reversal treatment, Lightlake could receive potential development and sales milestone payments of more than $55 million, plus up to double-digit royalties.
About Lightlake Therapeutics Inc.
Lightlake Therapeutics Inc., a biopharmaceutical company, is using its expertise in opioid antagonists to build a platform of innovative intranasal naloxone solutions to common addictions and related disorders. Lightlake is developing a treatment to reverse opioid overdoses, which have reached epidemic proportions in the United States. Lightlake has collaborated on clinical trials with the National Institute on Drug Abuse, part of the National Institutes of Health, and has entered into a licensing deal with a subsidiary of Adapt Pharma Limited. Lightlake also has completed a Phase II clinical trial to treat Binge Eating Disorder. For more information please visit: http://www.lightlaketherapeutics.com (http://www.lightlaketherapeutics.com/).
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Lightlake Therapeutics Inc.
445 Park Avenue, 9th Floor
New York, NY 10022
Dr. Roger Crystal, CEO
Investor Relations Contact:
Amato and Partners, LLC
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