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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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
Investor Relations Contact:
Amato and Partners, LLC
admin@amatoandpartners.com
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SOURCE Lightlake Therapeutics Inc.