NEW YORK, Sept. 25, 2015 (GLOBE NEWSWIRE) -- Lightlake Therapeutics Inc. (“Lightlake”) (OTCQB:LLTP), a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive, and eating disorders, announced today that Adapt Pharma Limited (“Adapt”), Lightlake’s partner for treating opioid overdose with intranasal naloxone, has had a New Drug Application (NDA) accepted for filing by the U.S. Food and Drug Administration (FDA) for NARCAN® (naloxone hydrochloride) Nasal Spray and Priority Review has been granted. NARCAN® Nasal Spray had previously been granted Fast Track Designation by the FDA and Adapt submitted an NDA in July 2015.
NARCAN® Nasal Spray is an investigational drug that is designed to provide a dose of naloxone in a nasal spray formulation. It is intended as an emergency treatment for known or suspected opioid overdose. Naloxone has been used as the standard treatment for opioid overdose for almost 45 years, but currently is only FDA approved in injectable formulations. NARCAN® Nasal Spray was developed in collaboration with the National Institute on Drug Abuse (NIDA). (See “About Naloxone” below for important safety information).
According to the Centers for Disease Control and Prevention (CDC), almost 24,500 lives were lost to opioid overdose in 2013, or an average of one life every 21 minutes. According to the CDC WONDER database, the majority of those deaths happened in people’s homes.
According to Substance Abuse and Mental Health Services Administration (SAMHSA), use of prescription opioids for the long-term management of chronic pain, or abuse of drugs such as heroin, may involve the potential risk of a life-threatening opioid overdose where breathing and heartbeat slow or stop. Opioids include morphine, codeine, methadone, oxycodone (e.g. OxyContin®, Percocet®), hydrocodone (e.g. Vicodin®, Lortab®), fentanyl (e.g. Duragesic®, Fentora®), hydromorphone (e.g. Dilaudid®, Exalgo®), and buprenorphine (Subutex®, Suboxone®).
“We’re very pleased that this significant milestone has been achieved,” 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 Naloxone
Naloxone administration is not a substitute for emergency medical care.
Due to the duration of action, the patient must be kept under continued surveillance and repeated doses of naloxone should be administered, as necessary, while awaiting emergency medical assistance. Other supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. Reversal of respiratory depression by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine may be incomplete. Use in patients who are opioid dependent may precipitate acute abstinence syndrome. Patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects should be monitored in an appropriate healthcare setting. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.
The following adverse reactions have been identified during use of naloxone hydrochloride in the post-operative setting: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in post-operative patients have resulted in significant reversal of analgesia and have caused agitation. Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated signs and symptoms of opioid withdrawal including: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes.
About Priority Review
Priority Review is granted by the FDA to medications that, if approved, would be significant improvements in the safety or effectiveness of treatment, compared to the standard therapy. Priority Review accelerates the FDA target action date to six months from the NDA acceptance date.
About Lightlake Therapeutics Inc.
Lightlake Therapeutics Inc. is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive, and eating 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.
CONTACT: 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
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