BioCorRx Aims To Help Combat Opioid Crisis With Implantable Naltrexone Drug Candidate BICX104

Image provided by BioCorRx of a naltrexone pellet

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In October last year, the Biden administration announced its new Overdose Prevention Strategy, an effort to crack down on the over-prescription of painkillers and allocate more than $11 billion in federal funding to prevention, treatment, and recovery services in an effort to address the worsening opioid crisis that has plagued the nation for the past three decades.

The announcement came as the opioid crisis reached record levels during the pandemic. Overdose deaths exceeded 100,000 in the 12-month period from March 2020 to March 2021 — about 73% of those deaths involved opioids.

BioCorRx Pharmaceuticals Inc., a biopharma company and a subsidiary of BioCorRx Inc. BICX specializing in developing treatments for substance use disorder, hopes to help drive the nation’s recovery from the crisis with its latest drug candidate BICX104. The candidate is a long-acting naltrexone pellet implanted under the skin, and is being developed to address both opioid and alcohol use disorders.

How Opioid Use Became a Public Health Crisis

The Trump administration declared the opioid crisis a public health emergency in 2017 after Oklahoma filed a lawsuit against 13 major pharmaceutical companies, alleging the manufacturers downplayed the risk of addiction and overdose.

According to the National Institute on Drug Abuse (NIDA), as many as 29% of patients who are prescribed opioids for chronic pain misuse them, and about 12% will develop an opioid-use disorder. Addiction and misuse lead to overdose. Between 1999 and 2016, an estimated 453,300 people died of opioid overdoses. 

In 2019, Purdue Pharma L.P. agreed to a $270 million settlement in the lawsuit filed by Oklahoma. That same year, Johnson & Johnson JNJ was ruled responsible for helping ignite the crisis and ordered to pay $572 million to the state.  

Last July, a proposal to settle the more than 3,300 pending lawsuits filed by states across the country could result in McKesson Corp. MCK, Cardinal Health Inc. CAH, AmerisourceBergen Corp. ABC, and Johnson & Johnson paying a combined $26 billion to states. Similar nationwide settlements are being negotiated with Purdue Pharma and Mallinckrodt plc MNKKQ to the tune of nearly $12 billion combined. 

The Treatment Potential of BioCorRx Pharma’s Drug Candidate

BioCorRx Pharma’s naltrexone drug candidate, BICX104, is one example of a treatment approach that could help tackle this crisis. With the support of approximately $9.2 million of non-dilutive grant funding from NIDA, BioCorRx is developing a biodegradable, subcutaneous pellet of naltrexone that could provide three months of craving-blocking therapeutic benefits. 

Approved by the Food and Drug Administration (FDA) in 1984, naltrexone is a non-addictive treatment that binds to receptors in the brain to prevent the release of dopamine. Without that dopamine release, patients won’t experience the same high of substances like opioids or alcohol, which can help block or reduce cravings while they’re trying to quit using the substance. Therapeutic levels of naltrexone can also block opioid overdoses. It is similar to naloxone, which is used to reverse opioid overdoses.

Until recently, the treatment has largely been given in tablet form, which requires the patient to take a new dose every single day. That has resulted in a high rate of patient noncompliance because, when combating an addiction, taking a medication that blocks the effects your addiction is craving becomes a struggle in and of itself. If and when the daily dose wears off and the cravings return, one is highly susceptible to relapse. In one 2008 study, researchers found that 85% of patients who received a naltrexone tablet prescription were no longer taking it just six months later. 

The implantable form that BioCorRx is developing hopes to tackle that noncompliance issue by making a treatment that lasts three months inside the patient’s system after implantation under the skin. For patients, that means they need to get the treatment just once to experience the craving-blocking benefits for a full three months. 

In May 2021, BioCorRx received FDA clearance to begin human clinical trials. In September, NIDA awarded the company a $3.5 million grant to fund the research, adding to the $5.7 million awarded to the company in 2020. 

The Phase 1 clinical trial will enroll up to 24 healthy volunteers and compare the naltrexone subcutaneous pellets to Vivitrol®, an FDA-approved injectable form of naltrexone manufactured by Alkermes Plc ALKS. While both use naltrexone, a Vivitrol injection lasts one month compared to the projected three-month release of BioCorRx’s implantable pellet. BioCorRx expects to begin the first in-human clinical trial of BICX104 in the first half of 2022. The trial will assess longevity, safety, and tolerability of BICX104, bringing it another step closer to market to help people suffering from opioid and alcohol use disorders. 

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