Antidote for Overdose Deaths Approved as Opioid Epidemic Surgesby
FDA clears nasal spray version of Narcan made by Adapt Pharma
Drug will be marketed in packages of two devices for $75
The antidote for prescription painkillers and heroin overdoses will now be sold as an approved nasal spray version that could make it easier for first responders and family members to revive drug addicts.
The U.S. Food and Drug Administration cleared for sale a nasal spray form of Adapt Pharma Inc.’s antidote called Narcan, which is chemically known as naloxone, to combat a growing epidemic of opioid drug abuse, according to a statement from the agency on Wednesday.
Naloxone has been available only as an injection, though police departments and addiction treatment groups have been retrofitting the drug vials with an atomizer to create a nasal spray.
“We are dealing with a public health crisis,” closely held Adapt’s Chief Executive Officer Seamus Mulligan said. “The need for it is staring us in the face.”
About 16,000 Americans died from prescription opioid painkiller overdoses in 2013 and another 8,000 died from heroin overdoses in the same year, a fivefold increase from 2001, according to the National Institute on Drug Abuse. Opioids include heroin and pain relievers such as OxyContin and Opana.
Fighting an Epidemic
States and the federal government have poured money into combating the overdose epidemic, making naloxone manufacturing a more attractive prospect than in previous years. President Barack Obama unveiled an effort last month to boost naloxone prescribing as well as a commitment from CVS Health Corp. to expand the number of pharmacies that will offer the drug over the counter in states that allow residents to get certain medications without actually having a condition that needs treatment.
Indivior Plc is waiting to hear from the FDA before the end of this year about its application to sell the antidote. Nasal naloxone is estimated to generate as much as $100 million in peak sales for Indivior if approved, CEO Shaun Thaxter said on a Nov. 3 earnings call. Amphastar Pharmaceuticals Inc. is also working on a nasal spray version of naloxone and plans to file an application for approval to the FDA this year, President Jason Shandell said on a Nov. 12 earnings call.
Adapt plans to price its naloxone in packs of two single-spray devices for $75 for customers designated “public interest,” including law enforcement, firefighters and colleges, Mulligan said. Sometimes one dose isn’t enough and another spray may be needed. Adapt bought the rights to the Narcan brand, which is commonly associated with any naloxone since it was the name of the drug’s original version approved in 1971 that has since been discontinued.
The kits currently on the market that users must improvise to administer as a spray are about $45 per dose, or $90 for two sprays.