FDA panel backs prescribing overdose reversal drug with opioids

(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Tuesday narrowly recommended prescribing the opioid overdose reversal drug, naloxone, along with addictive painkillers.

The panel voted 12-11 in favor of labeling changes for opioids that recommend co-prescribing the overdose antidote, concluding a two-day discussion on ways to make the potentially life-saving drug readily available.

The recommendation underscores concerns about the growing opioid overdose epidemic that claimed more than 49,000 American lives last year.

When administered quickly, naloxone helps reverse the effects of an overdose and saves lives.

The prescription of naloxone could facilitate a healthy dialogue between patients and the healthcare provider, Maryann Amirshahi, a panel member who voted in favor, said.

But co-prescribing naloxone to all patients who are prescribed painkillers could increase annual healthcare costs by $63.9 billion to $580.8 billion, according to FDA studies.

“I think co-prescribing is an expensive way to saturate the population with naloxone. The at-risk population is not necessarily the ones that are being prescribed new narcotics,” said Mary Ellen McCann, associate professor of anesthesia at Harvard Medical School, a panelist who voted against the decision.

“I’m concerned about a person going in with a broken arm and ending up with $30 of a codeine product and a (naloxone) autoinjector at $4,000 plus.”

Branded versions for treating opioid overdose include Adapt Pharma’s Narcan nasal spray and Kaleo Inc’s Evzio autoinjector.

Robert Kramer, chief operating officer of Emergent BioSolutions Inc (EBS.N), which bought Adapt Pharma this year, said the FDA’s cost estimates were “inflated”, adding the number includes the price of Narcan and Kaleo’s Evzio, which has a list price of over $4,000.

The list price is not necessarily what patients actually pay and “out-of-pocket” costs vary depending on the duration of the treatment and individual healthcare plans.

A pack of Narcan containing two doses lists at a price of $125, while generic naloxone retails at around $40 per dose.

“A fully implemented co-prescription program targeting opioid prescription associated with the highest risk of opioid overdose would cost an estimated $115 million per year as opposed to the $64 billion number,” Kramer said.

Kaleo announced last week an authorized generic of Evzio, which will be available at a list price of $178 for a pack of two doses.

Naloxone is currently made available through distribution and prescription programs in pain clinics and opioid treatment centers, as well as “take-home” programs among high-risk patients.