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

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

LOUISVILLE, Ky. (WAVE) — Julie Hofmans’ Saturday afternoon ride on her horse, Hugo, means more than just overcoming obstacles.

She came to Brownsboro Farm in Crestwood to participate in “The Pace” event in honor of 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, unaware that 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 Xanax, and it had fentanyl in it and it cost him his life.

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

“While he was on life support, I just knew it couldn’t be over,” Hofmans said. “I knew 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 led her to connect with Lee Warren, the COO of US World Meds., a Louisville-based company that is working to fulfill Hofmans’ life-saving hopes through a product called ZimHi. .

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

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

ZimHi is designed as a more efficient way to deliver naloxone.

Currently, Narcan is the best known product on the market.

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

ZimHi is five milligrams of naloxone injected into the victim’s outer thigh, and Warren said it was “100% bioavailable immediately.”

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

ZimHi is coming to 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 poisonings in the 12 months ending January 2022. 67% of those deaths involved synthetic opioids like fentanyl.

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

Only two milligrams of fentanyl is considered a life-threatening dose; it’s especially dangerous for someone who doesn’t have an opioid tolerance.

Because of how quickly fentanyl can kill, Warren thinks his shot weighs well over five milligrams.

“Well, that’s amazing,” Warren said. “Right now, the opioid crisis kills more people than anything else on an annual basis, including car wrecks, cancer, anything else, [is] the number of people who die from opioid overdoses.

Warren and Hofmans hope this new product will give thousands of people a second chance in the years to come, a second chance that Hofmans’ son didn’t get.

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

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