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OC firm fighting addiction seeks volunteers for clinical trial

Sure, you’ve heard that drug- and alcohol-related deaths soared during the pandemic, but the impact on children — who should be going to Scout meetings and soccer games, play practice and karate class — is truly stupefying.

From 2019 to 2020 in Orange County, drug and alcohol deaths among kids aged 10-17 exploded by 800%.

From 2020 to 2021, they shot up another 122%.

But we come to you today not just with a horrifying problem, but with potential answers rooted in chemistry and science rather than spirituality and faith (where addiction treatment has long dwelled). After years of work on bringing a medical implant that can blunt the effects of opioids on the brain to the U.S., the Anaheim company BioCorRx has dosed the first patient in its Phase I clinical trial of BICX104 — and is looking for another 20+ healthy volunteers in the O.C. area to participate.

“More than 107,000 Americans died of drug overdoses in 2021, which roughly translates to one U.S. overdose death every 5 minutes,” said Brady Granier, president and director of BioCorRx and CEO of BioCorRx Pharmaceuticals, in a statement.

“Not only is this tragic and staggering, but gaps in opioid use disorder treatment continue to widen. Our goal is to quickly bring BICX104 to market and provide an additional treatment option for those suffering from substance use disorders. With the first subject being dosed, we are now focused on enrolling and scheduling the remaining subjects.”

The trial needs healthy participants — not folks currently wrestling with substance use disorder — because this phase will measure how long the implant releases the drug naltrexone at therapeutic levels, as well as safety at the implantation site, Granier said.

The study is led by Dr. Joel M. Neutel, director of research at the Orange County Research Center in Tustin. Interested? Contact information is at www.ocresearchcenter.com.

BioCorRx has received grants totaling $9.3 million from the National Institute on Drug Abuse — part of the National Institutes of Health — for this research.

What is it?

The drug naltrexone binds to the brain’s opioid receptors so heroin, oxycontin and fentanyl can’t.

It’s already available as a daily oral medication and as an injection lasting about a month, but “poor compliance” by patients plagues those delivery methods, meaning it’s easy for people to simply decide to stop taking them.

BioCorRx's sustained-release naltrexone implant. (Photo by Paul Bersebach, Orange County Register/SCNG)
BioCorRx’s sustained-release naltrexone implant. (Photo by Paul Bersebach, Orange County Register/SCNG)

BioCorRx’s naltrexone implant makes impulsively quitting much more difficult. It’s inserted under the skin and releases medication steadily, providing a “continual blockade” of the brain’s opioid receptors for up to three months, the company said in its grant application.

“This can prevent patients from being affected adversely by almost any opioid relapse event, while improving efficacy and adherence to behavioral programs that support long term management and recovery,” it said.

The drug has been safely used in Russia as Prodetoxone for more than a dozen years, and studies from Russia and Australia have found that naltrexone implants improved outcomes for opioid-addicted people beyond what’s seen with orals and injectables.

Reviewers with NIDA said BioCorRx has a “strong rationale for the technology based on previous basic research and clinical experience,” and that the drug “has a high likelihood of progressing to an approved treatment in the U.S.,” according to a company statement.

But recovery is not just about science, the company maintains. It also requires that other piece.

“We offer a unique treatment philosophy that combines medical intervention and a proprietary cognitive behavioral therapy program, plus peer support program, specifically tailored for the treatment of alcoholism and other substance abuse addictions for those receiving long-term naltrexone treatment,” the company said in Security and Exchange Commission filings.

The trial is randomized and will compare the naltrexone implant to an injectable version of the drug.

Alcoholics Anonymous uses sobriety coins representing the amount of time the member has remained sober. (PHOTO BY, BRUCE CHAMBERS, ORANGE COUNTY REGISTER/SCNG)
Alcoholics Anonymous uses sobriety coins representing the amount of time the member has remained sober. (PHOTO BY, BRUCE CHAMBERS, ORANGE COUNTY REGISTER/SCNG)

Tragedy

Today’s drugs are too powerful — and too dangerous — to be left to up-by-the-bootstraps-willpower alone.

That was made clear to us some years back by an O.C. doctor whose kick-boxing injury led him to an opioid addiction that nearly cost him his medical license. “It took away the pain; all the pain,” he told us. “In the brain, in the heart, in the body. That’s what we’re up against.”

The current carnage underscores the need for a truly integrated approach. In Orange County, a total of 4,649 people died from drug- and alcohol-related causes over the five years ending with 2021, according to a recent analysis by the Orange County Health Care Agency.

Drug and alcohol deaths for all ages were up 32% from 2019 to 2020, and another 30% from 2020 to 2021, with the most dramatic changes in mortality among the aforementioned youth.

In pre-pandemic days, the number of deaths among 10-17-year-olds would normally be none or 1, the HCA said. But in 2020, there were nine. In 2021, there were 20.

In the next-youngest group, 18 to 24, deaths shot up by 150% from 2019 to 2020, and remained consistent from 2020 to 2021.

Opioids were overwhelmingly responsible for these deaths, and the deaths were overwhelmingly accidental (99% in 2021).

The Alexander Neville Foundation and VOID (@victimsofillicitdrugs) rally in front of Snap Inc. headquarters in Santa Monica, pressuring SnapChat to do more against drug dealers using the site to sell fentanyl, on Friday, January 21, 2022.(Photo by Axel Koester, Contributing Photographer)
The Alexander Neville Foundation and VOID (@victimsofillicitdrugs) at Snap Inc. headquarters in Santa Monica in January, pressuring SnapChat to do more to stop drug dealers on the platform. (Photo by Axel Koester, Contributing Photographer)

“Fentanyl was nonexistent among overdose deaths in youth under 18 years of age until 2019,” the HCA said. “The overall rate for fentanyl-involved overdose deaths rose 8.5-fold within the 5-year timeframe, from 1.1 per 100,000 persons to 9.4 per 100,000 persons.”

Behind all the numbers, these are people who were someone’s daughters and sons. In 2020, there was even one death of a child younger than 10. The backstory there tends to be when a kid gets hold of his/her parents’ stash.

It’s long past time for science to be wedded to traditional social supports. Addiction treatment must come out of its silo and become an integral part of the medical health care system.


Source: Orange County Register

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