Lightlake Therapeutics Inc. Announces Adapt Pharma Limited Submits NDA To FDA For Narcan® (naloxone) Nasal Spray

Jul 29, 2015, 09:00 ET from Lightlake Therapeutics Inc.

NEW YORK, July 29, 2015 /PRNewswire/ -- Lightlake Therapeutics Inc. ("Lightlake") (OTCQB: LLTP), a specialty pharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, announced today that Adapt Pharma Limited ("Adapt"), Lightlake's partner for treating opioid overdose with intranasal naloxone, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Narcan® (naloxone) Nasal Spray, an investigational drug intended to treat opioid overdose. 

Narcan® Nasal Spray has been granted Fast Track Designation by the FDA.  Narcan® Nasal Spray was developed in collaboration with the National Institutes on Drug Abuse (NIDA).

There is a rapidly growing opioid overdose epidemic in communities across America.  Centers for Disease Control and Prevention (CDC) data indicates that almost 24,500 lives were lost to opioid overdose in 2013 and 76% of these deaths occurred in a non-medical setting, most frequently at home.  Over two-thirds of these deaths were due to prescription opioids, a commonly prescribed class of pain medication. 

The Narcan® Nasal Spray has been developed in response to calls for new easy-to-use formulations of naloxone for use in the communities and homes where the majority of overdose related deaths occur. 

"We're very pleased to see such progress.  Through collaborating with NIDA, Lightlake has dedicated a tremendous amount of effort into this treatment, and it is exciting to reach this significant milestone," stated Dr. Roger Crystal, M.D., CEO of Lightlake.

In December 2014, Lightlake announced a licensing deal with a subsidiary of Adapt.  As per the terms of the deal, 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 Opioid Overdose

The number of opioid overdose related deaths continues to increase. Data from CDC WONDER database indicates opioid overdose led to the loss of almost 24,500 lives in America in 2013, a four-fold increase since 1999.  Additionally, the Drug Abuse Warning Network (DAWN), a public health surveillance system managed by the Substance Abuse and Mental Health Services Administration (SAMHSA), estimated that in 2011 there were over 740,000 emergency department visits involving the non-medical use of prescription opioids and heroin.  With the majority of opioid overdose related deaths occurring in a non-medical setting, there is a need for more user friendly formulations of naloxone suitable for use in the community.

About Lightlake Therapeutics Inc.

Lightlake Therapeutics Inc., a specialty pharmaceutical company, is using its expertise in opioid antagonists to build a platform of innovative intranasal naloxone solutions to common addictions and related disorders.  Lightlake has entered into a licensing deal with a subsidiary of Adapt Pharma Limited with respect to a treatment to reverse opioid overdoses, which have reached epidemic proportions in the United States.  Lightlake also has collaborated on clinical trials with the National Institute on Drug Abuse, part of the National Institutes of Health, with respect to this treatment.  In addition, Lightlake has completed a Phase II clinical trial to treat Binge Eating Disorder.  For more information please visit: www.lightlaketherapeutics.com.

Forward-Looking Statements

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 press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.

Corporate Contact:
Lightlake Therapeutics Inc.
445 Park Avenue, 9th Floor 
New York, NY 10022 
Dr. Roger Crystal, CEO 
(212) 829-5546 
investor.relations@lightlaketherapeutics.com

SOURCE Lightlake Therapeutics Inc.



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