It’s good to be profitable and successful, but there’s more to a life in medicine for some health care professionals.
For some, you should strive to do something significant and give back to the community as well.
That’s part of the philosophy that drives Kaléo Pharma, a Richmond-based pharmaceutical business whose name is derived from the Greek for “calling” or “purpose.”
The company, founded by twins Eric and Evan Edwards (and previously named Intelliject), announced Tuesday that it is donating 50,000 devices that deliver a drug used to treat individuals who have overdosed on opioids. The donation through the company’s Kaléo Cares Product Donation Program was made in honor of a rally planned for Sunday at the National Mall in Washington to increase awareness of a growing national problem of opioid abuse.
It was announced on the syndicated The Dr. Oz Show by Eric Edwards, chief medical officer and vice president of research and development for Kaléo. “We believe we can play a small role in reversing this tragedy,” he says.
The rally will be staged by Facing Addiction, a New York-based nonprofit.
“It is time for all of us to collectively face addiction, and this donation from Kaléo will help save so many lives,” Greg Williams, a co-founder of Facing Addiction, says in a news release.
Naloxone is a key weapon in the battle against a nationwide wave of opioid abuse. The Kaléo product, Evzio, is an auto-injector that can be administered by a layman and that delivers a dose of the drug, which actually reverses a drug overdose.
Naloxone has been in use since the 1970s, but it is usually administered with a hypodermic needle or through a nasal dose by a trained health care worker. What sets Evzio apart is that it is designed for use by almost anyone.
Drug overdoses are now the leading cause of injury-related death in the United States, killing more Americans than car wrecks, according to a recent report from the Trust for America’s Health and the Robert Wood Johnson Foundation.
In Virginia, there were 386 deaths in 2013 from prescription opioid abuse, according to REVIVE! a state initiative to raise awareness and combat opioid abuse. That’s a 1,578 percent increase from 1999, when prescription opioids (the most commonly abused include fentanyl, hydrocodone, methadone and oxycodone) accounted for the death of 23 Virginians.
REVIVE! reports that deaths from heroin abuse also are rising in the state, from 49 in 2010 to 213 in 2013. Most drug-related deaths previously occurred in western Virginia, but are now spread evenly across the state. In July, state lawmakers expanded access to naloxone.
Since it’s easy to use and designed for use by most anyone and in the home, Evzio may help rein in those numbers, according to the U.S. Food and Drug Administration.
“Making this product available could save lives by facilitating earlier use of the drug in emergency situations,” says Bob Rappaport, a medical doctor and director of the FDA’s Center for Drug Evaluation and Research’s Division of Anesthesia, Analgesia and Addiction Products.
The 50,000 donated units will be distributed to public health departments across the nation where there is the greatest need, as determined by U.S. Department of Health and Human Services research, according to Kaléo. The donations through health departments are designed to get Evzio to people without insurance who rely on public health facilities, Spencer Williamson, Kaléo’s president and CEO, says in a news release.
In addition to the donation announced Tuesday, Kaléo is working with several national campaigns to provide free or reduced cost Evzio to people and communities in need, including the Clinton Foundation.
Kaléo also is a participant in the America Starts Talking campaign, a nationwide effort to increase awareness of addiction and abuse.
Origins and Beyond
The Edwards twins were in their teens when they came up with an idea that led to the formation of Kaléo. As Eric Edwards tells it, they were the “most allergic children ever.”
They grew up in a world of in which exposure to everyday items could trigger a life-threatening reaction, and they thought there should be an easier way to administer a dose of Epinephrine (adrenaline), the drug of choice to treat a severe allergic reaction.
“We knew what it was like to experience a life-threatening situation,” he says.
That led to the development of Auvi-Q, an auto-injection device to deliver a single dose of Epinephrine.
Evzio and Auvi-Q are compact, portable and easy to use in an emergency. Each includes an audio component that will walk someone through administration of the product in an emergency. That helps in a panic situation, such as someone walking into a room to find a loved one collapsed on the floor, unresponsive and not breathing.
With Evzio, people without training who have never seen the product can deliver a proper dose correctly about 94 percent of the time. That rises to 100 percent with training, according to Kaléo.
Costs and Access
There have been concerns raised nationally over the rising price of the generic drug Naloxone.
Edwards notes that Evzio differs significantly from the traditional generic drug in the way it’s administered, and by whom it is administered.
For starters, Evzio is targeted for in-home use, to be delivered by a family member or caregiver, while the generic drug is designed to be given by a heath care provider and requires training to be administered.
It is available through a prescription, which can be written when an opioid is prescribed. Evzio’s price was set to align with coverage by insurance providers, including federal programs Medicare, Tricare and the Department of Veterans Affairs. The out-of-pocket cost for most people with insurance is less than $20, Edwards says. That’s a one-time cost, versus a monthly expense, and has to be renewed just once a year.
Edwards estimates that Evzio is available to about 75 percent of the population through insurance plans, and that the company is trying to make it available to all who need it through its donations and cost-reduction programs.
Evzio was fast-tracked for use by the FDA, which gave its approval to the device in April 2014.
Problems, of course, don’t just occur with intentional drug abuse. Some people may accidentally overdose if they use the drug with alcohol, through interaction with other medications, take their medication improperly, or a child in the household may accidentally ingest a medication.
Evzio has no effect if given to someone who has not taken an opioid. Administered to someone who is dependent on an opioid, it may induce symptoms of withdrawal. You still need to call emergency health care workers after giving it to someone who has overdosed.
Kaléo has four products in development, with one in trials. Edwards declined comment on the type of medications in the works.
Kaléo’s team feels uniquely called to deal with life-threatening or serious medical conditions, according to Edwards. The company focuses on the big questions, such as, “How many lives have we helped saved this week?”
The answer? About two a week, or about 126 in total. That’s the number estimated from searches of medical literature and of reports from recipients of grants through the company’s Kaléo Cares foundation, and covers a period from October 2014 through August.
Eric Edwards is active in the Christian Medical and Dental Association. As you’d expect from someone whose company’s name was derived from a word meaning “calling,” faith has had an impact on his career.
“I’m pretty open that I feel this is a way I can use my God-given talent,” he says.