Louisville-based company receives FDA approval for injectable overdose-reversal device

ZimHi is the first ever FDA-approved injectable Naloxone device that can reverse the deadly effects of an overdose.
Published: Sep. 26, 2022 at 8:09 PM EDT
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LOUISVILLE, Ky. (WAVE) - Julie Hofmans’ Saturday afternoon ride on her horse, Hugo, means more than simply clearing the hurdles.

She came to Brownsboro Farm in Crestwood to ride in “The Pace” event to honor her son, Wyatt Williamson.

“[When I’m riding] I feel Wyatt,” Hofmans said. “I feel his strength”

Williamson, 23, died on April 5, 2020 when he took a pill he thought was Xanax, not knowing it was laced with fentanyl.

“He didn’t overdose,” Hofmans said. “He didn’t take a handful of pills. He wasn’t trying to do anything wrong. He just took a Xanax that he thought was a Xanax, and it had fentanyl in it and it took his life.”

While Hofmans sat with her son in the hospital, she felt an overwhelming determination to tell his story, hoping it could save a life and prevent another mother from burying her child

“While he was on life support, I just knew that it couldn’t be over,” Hofmans said. “I knew that for 23 years of the wonderful life he had, I had to do something. And I was like, ‘I want to save other families and I want to save other lives if I can, with Wyatt’s help.’”

Her advocacy journey brought her in touch with Lee Warren, the Chief Operating Officer of U.S. World Meds., a Louisville-based company that’s been working to put Hofmans’ life-saving hopes into action through a product called ZimHi.

ZimHi is the first ever FDA-approved injectable Naloxone device that can reverse the deadly effects of an overdose.

“So you would just open it up and you pull it out,” Warren said. “You pull off the needle cap. You press it to the thigh and you push.”

ZimHi is designed as a more effective way to administer naloxone.

Currently, Narcan is the most well-known product on the market.

It treats an overdose with the same drug, naloxone, but is administered as a nasal spray, shooting four milligrams of naloxone up the victim’s nose.

ZimHi is five milligrams of naloxone shot into the victim’s outer thigh, and Warren said it is “100 percent bio-available immediately.”

“Unfortunately when you [overdose], a lot of times you end up with a lot of convulsion around the face,” Warren said. “And then the fact that COVID hit and this patient population, you now don’t have to touch the patient. For first responders, that’s very nice.”

ZimHi arrives on the market at a time when fentanyl overdoses have never been higher in America.

According to the Centers for Disease Control and Prevention, 107,375 people in the United States died of drug overdoses and drug poisonings in the 12-month period ending in January 2022. A staggering 67 percent of those deaths involved synthetic opioids like fentanyl.

Some of these deaths were attributed to fentanyl mixed with other illicit drugs like cocaine, methamphetamine and heroin, with many users unaware they were actually taking fentanyl.

Only two milligrams of fentanyl is considered a potentially lethal dose; it’s particularly dangerous for someone who does not have a tolerance to opioids.

Because of how fast fentanyl can kill, Warren believes his shot weighs much more than five milligrams.

“Well, it’s unbelievable right,” Warren said. “Right now, the opioid crisis is killing more people than anything else on an annual basis, including car wrecks, cancer, anything else, [is] the amount of people who are dying of opioid overdoses.”

Warren and Hofmans are hoping this new product will give thousands of people second chances in the years to come, a second chance Hofmans’ son did not get.

“It happened to my family,” Hofmans said. “It happened to Wyatt. So to me, if I’m upholding Wyatt, and I’m saying, ‘don’t let this happen to you, to your family,’ I think Wyatt would be proud. I really do.”