“Heroin Antidote” Nasal Spray Gets FDA Approval

Narcan Nasal Spray can be administered in an emergency to reverse the effects of opioid overdose until help arrives.

Heroin usage has reached epidemic proportions in the United States — and families in Philadelphia have certainly been feeling its wrath. In fact, deaths nationally from the drug have quadrupled from 2002 to 2013, according to the Centers for Disease Control and Prevention.

Adapt Pharma Limited, which has its U.S. headquarters in Radnor, Pa., has a drug to help combat the heroin overdose problem — and overdoses from other opioids. On Thursday, it just won Food and Drug Administration approval.

Called Narcan Nasal Spray, the product delivers a 4 mg dose of naloxone which can be administered in an emergency by family members, caregivers or others to reverse the effects of an opioid overdose until help arrives. For years, naloxone has been used as the standard treatment for opioid overdoses, but was only FDA approved in injectable formulations. Now it can be administered as easy as allergy medication.

The FDA said that “when someone overdoses on an opioid, it can be difficult to awaken the person, and breathing may become shallow or stop – leading to death if there is no medical intervention.” But if naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.

“We cannot stand by while Americans are dying,” said Dr. Stephen Ostroff, acting commissioner of the FDA. “While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”

Adapt Pharma says it aims to keep pricing transparent. Group purchasers like law enforcement officials, schools and first responders are eligible for the discounted price of $37.50 per for one 4mg nasal spray device.