FDA Approves Nasal Spray to Reverse Narcotic Painkiller Overdose

Lightlake Therapeutics Therapeutics (OTCMKTS:LLTP) jumped in morning trading after the early stage biopharmaceutical company said the U.S. Food and Drug Administration (FDA) has approved NARCAN (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose.

Opioids include prescription medications such as oxycodone, hydrocodone and morphine, as well as the illegal drug heroin, according to the FDA. Another 8,000 additional deaths involved heroin, which many addicts switch to after becoming addicted to more-expensive legal drugs. In 2013, close to 52 percent of the 43,982 drug overdose deaths in the country were related to prescription drugs based on the CDC data. When administered quickly, naloxone can counter the overdose effects, usually within two minutes, according to the FDA.

The spray, developed by privately held Adapt Pharma, the latest venture of serial pharmaceuticals entrepreneur Seamus Mulligan, uses naloxone, a drug used to treat opioid overdose for almost 45 years but approved only in injectable forms.

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“Combating the opioid abuse epidemic is a top priority for the FDA”, acting FDA Commissioner Stephen Ostroff, MD, said in a statement.

Until now, the FDA had approved only the injectable form of naloxone. “We can not stand by while Americans are dying”. The nasal spray naloxone received fast-track designation and priority review. NARCAN is sprayed into one nostril while the patient is lying on his/her back and can be repeated if necessary. Key in the development of the nasal spray was the National Institute on Drug Abuse (NIDA), which formed a public-private partnership by designing and conducting the clinical trials needed to determine the intranasal formulation’s efficacy.