It’s a well-known and lethal problem: About 90 percent of recovering addicts relapse and use drugs such as heroin again.
The overwhelming majority of these falls from grace occur within one month of successfully completing treatment, and the results can be deadly, according to several studies.
BioCorRX, a small Anaheim company, believes it can help break this vicious cycle, and the National Institute on Drug Abuse is inclined to agree. The institute — part of the National Institutes of Health — has awarded BioCorRX a grant to help develop a naltrexone implant to treat what is officially called “opioid use disorder.”
But the implant also is effective in battling alcoholism, a more widespread problem that could use more successful treatment, officials said.
BioCorRX will get $2.84 million for the first year of the grant, which runs through January 2020, and can get $2.83 million for the second year “based on satisfactory progress of the project and availability of funds,” according to a company statement.
The drug naltrexone is an opioid antagonist that blunts highs even if patients use drugs again. It’s already available as a daily oral medication and as an injection lasting about a month — but “poor compliance” plagues those methods, which means it’s easy for people to simply decide to stop taking them.
BioCorRx’s naltrexone implant — with the futuristic name BICX102 — 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 NIH is funding more than 100 research projects throughout the nation aimed at developing medications to battle opioid addiction, according to NIH data. Current grants total more than $64 million and include two projects at UCLA, one of which specifically targets heavy-drinking smokers with a combination of varenicline and naltrexone.
BICX102 has been safely used in Russia as Prodetoxone for more than a dozen years, and studies from Russia and Australia found that naltrexone implants improved outcomes for opioid-addicted individuals beyond what’s seen with orals and injectables.
“The implant has been used around the world for 20 years successfully with few problems,” said Brady Granier, CEO of BioCorRX. “But in the United States, it hasn’t been approved yet by the FDA. So that’s the ultimate finish line. A lot of people are waiting for FDA approval before they’ll feel comfortable using it on patients — and before health insurers and government payers will cover for the treatment.”
NIDA reviewers said BioCorRx has a “strong rationale for the technology based on previous basic research and clinical experience,” and that “extensive experience with the parent drug and delivery technology (clinical) suggest that the development plan has a high likelihood of progressing to an approved treatment in the U.S.,” according to a company statement.
BioCorRX hopes to win that approval in about four years. It has been pouring money into the effort for years, and the grant is a big step toward that approval — and perhaps toward wider use of medication to battle addiction.
“This grant is a really big deal for us,” Granier said.
It comes as California and the nation pivot toward a more medical approach to the problem, which has traditionally been treated primarily as a behavioral issue. In the big picture, BioCorRx combines both approaches to attack addiction.
“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 says in Security and Exchange Commission filings.
“We are also engaged in the research and development of sustained release naltrexone products for the treatment of addiction and other possible disorders.”
Its alcoholism and opioid addiction treatment program is called the BioCorRx Recovery Program. Before this grant, the company’s primary source of operating funds has been “from proceeds from private placements of convertible and other debt and the sale of common stock,” according to its SEC filings.
Federal officials have pegged the cost of the opioid epidemic at more than a half-trillion dollars a year.
“Getting BICX102 to the market quickly is a national priority,” BioCorRX said in its grant application. “We know from extensive non-clinical and clinical studies that BICX102 will be effective.”