BOSTON – The price of an injectable overdose-reversing drug designed for use by laypeople has skyrocketed, prompting outrage from first-responders, health advocates and elected officials.

Kaléo, a Virginia-based pharmaceutical company, has raised the cost of its two-dose naloxone auto-injector from $690 to $4,500 in just three years, according to Truven Health Analytics, which tracks prescription drug prices.

The device sold under the brand name Evzio is voice-guided and specifically made for people with no medical training to administer the life-saving drug to stop overdoses in opioid and heroin users.

“This is pure, unadulterated profiteering,” said Sander Schultz, Gloucester’s emergency medical services coordinator, whose EMTs regularly use naloxone. “The pharmaceutical companies are gouging people who are dependent on these drugs to save lives. It’s obscene.”

Scultz said the devices, approved by the U.S. Food and Drug Administration in 2014, are not always effective because they only deliver only a 0.4 milligram dose, which isn’t enough to stop many overdoses triggered by fentanyl-laced heroin and other potent opioids.

“We’re routinely seeing 4, 6 or 8 milligrams needed to reverse overdoses,” he said.

Naloxone counteracts the effects of opioids by blocking certain receptors in the brain.

Outrage over the price of Evzio comes at a time when pharmaceutical companies are facing intense scrutiny over pricing, and as federal and state officials wrestle with an epidemic of opioid abuse that led to nearly 2,000 fatal overdoses in Massachusetts last year.

Massachusetts Sens. Elizabeth Warren and Ed Markey, both Democrats, were among 30 lawmakers who penned a recent letter to Kaléo CEO Spencer Williamson asking for information on Evzio’s price structure and why the company raised prices. New Hampshire Sen. Maggie Hassan, a Democrat, also signed the letter.

“Such a steep rise in the cost of this drug threatens to price out families and communities that depend on naloxone to save lives,” the Feb. 8 letter read.

The company’s website points out that people with commercial insurance and a prescription can purchase Evzio with no out-of-pocket cost. Those without private insurance or annual household incomes under $100,000 can get Evzio at no cost.

In a statement, Williamson said Kaléo is not trying to compete with other generic naloxone products for bulk sales to emergency responders.

“Evzio was not designed for use by first-responders, public health departments or emergency medical services,” he said. “Evzio was specifically invented, developed and approved for lay users via a prescription by their physician, through outpatient retail pharmacies.”

To date, Kaléo has donated nearly 200,000 doses to health departments and first-responders, Williamson said, and plans to donate another 100,000 this year. 

“To put the scope of these donations in perspective, about 40 percent of all Evzio auto-injectors shipped through the end of last year were charitable donations,” he said.

In 2014, the Massachusetts Department of Public Health received a donation of about 1,400 Ezvio auto-injectors, which it distributed to police and fire departments, according to a spokesman. The state hasn’t purchased any of the injectors, which average about $3,900 wholesale for a two-pack. 

Schultz said the donations are a “gimmick” to lure state and local governments into future purchases.

Ezvio accounted for nearly 20 percent of the naloxone dispensed through retail outlets between 2015 and 2016, and for nearly half of all naloxone products prescribed to patients between ages 40 and 64, which represents the majority of naloxone users, according to the FDA. 

Last week, Attorney General Maura Healey issued an advisory on Evzio prices, reminding first-responders that a state bulk-purchasing program distributes naloxone at reduced costs.

The program charges first-responders $20 per dose. Local governments, schools and others pay the price negotiated by the state, now about $35 a dose. Prices for wholesale naloxone doses vary widely but generally run between $75 and $100.

More than 80 cities and towns – including Haverhill, Beverly, Gloucester and Newburyport – are part of the program, which distributed 8,500 doses in 2016, according to Healey’s office.

Money for the bulk-purchase fund comes from a 2015 agreement between Healey and Amphastar Pharmaceuticals, which provided the state $325,000 to acquire and distribute the medicine at reduced rates. Healey was investigating skyrocketing prices for the drug at the time of the settlement.

Other state programs give money to police and fire departments in high-risk areas to buy naloxone and to train first-responders to administer it. The Legislature put $1 million toward those programs in the current budget.

First-responders also get naloxone through agreements with hospitals and nonprofits such as the Gloucester-based Police Assisted Addiction and Recovery Initiative.

Individuals can buy injectable or nasal spray naloxone at local pharmacies with a prescription. 

Eric Linzer, a spokesman for the Massachusetts Association of Health Plans, which represents most of the large insurers in the state, said consumers ultimately pick up the tab for drug price increases that they don’t pay for directly.

“What Kaléo and other companies fail to recognize is that the rising cost of this drug is built into insurance premiums,” he said.

Linzer said claims by pharmaceutical firms that price hikes for naloxone and other medicines are needed to fund research and development don’t stand up to scrutiny.

“There are products that have been on the market for decades — such as insulin and epinephrine — that have seen significant price increases,” he said. “But there’s no rationale for it.”

Christian M. Wade covers the Massachusetts Statehouse for North of Boston Media Group’s newspapers and websites. Email him at cwade@cnhi.com.