Brady Granier, CEO BioCorRx Pharmaceuticals

What is naltrexone?

Naltrexone is an opioid antagonist and that’s the opposite of an agonist which is opioids: heroin, methadone, oxycontin, fentanyl. Those are all agonists, so they engage with this receptor in the brain, and they elicit a response, whereas naltrexone is the antagonist.

Read more

It engages with that same receptor, so it’s a competition of sorts so it engages in that same receptor and it will not elicit a response. So if you have naltrexone in your system, in appropriate quantities and it’s engaging those receptors, it acts as a shield. In the event that opioids enter the system, they can’t engage in those receptors to elicit that response, which may be euphoria or respiratory depression, which can lead to death.

What do we know about the safety of naltrexone?

Naltrexone is very widely known as a relatively safe medication. It’s been around for decades. It’s been approved several times for several indications and routes of administration. So the safety profile is really good. There’s some side effects.

Read more

The most common side effects that we hear from people taking it, especially in oral form would be some GI complaints, nausea, vomiting, but things that are mostly self-limiting. But it’s a medication that doesn’t cause dependency upon it. If someone stops taking it after taking it for some time, there’s no withdrawals from it. So it’s not a drug that someone needs to be weaned off, per se. But again overall it has a really, really safe profile, and the more research we do on it, the more we see that it is a very safe drug even at high levels (if someone gets a very, very high level of it). So safety profile is great on this medication.

Could Naltrexone be used for methamphetamine use disorder?

As I mentioned earlier naltrexone is a very safe medication from literature that’s out there. But not only is it safe, it has the potential to treat many other indications. There’s been a lot of research on the use of naltrexone in any form, not just BICX104, an implantable pellet form, but orally, even with the injectable.

Read more

It’s such a special drug that doesn’t get the attention it deserves. But anecdotally, we’ve seen naltrexone work with pain management at certain levels. We’ve seen it work for gambling addiction, sex addiction- even there’s some studies on low dose naltrexone with ADHD and autism and fibromyalgia. The list goes on and on. So it’s a very interesting drug. It just it doesn’t get studied enough, unfortunately, for many reasons. I mean it’s an old drug and off patent. It has a molecule itself that you know, that hinders a lot of research that should be taking place with it, but another you know, epidemic that we’re faced with today is the methamphetamine epidemic, which is starting to get more publicity. So that’s the next plague, you know, scouring the world and especially the United States and there’s been some studies on the use of naltrexone in combination with another drug, bupropion, and that showed some good results with the treatment of methamphetamine. So the short answer is, you know, I believe, yes, this naltrexone can be used to treat methamphetamine. More research needs to be done. It is used in other countries for that indication off label. So I do believe It can be effective and more research needs to be done and hopefully we plan to do that here pretty soon as well.

What is BICX104?

BICX104, simply put, is an implantable pellet of that medication, naltrexone, that we’ve discussed being a safe medication that blocks the opioid receptors. So, BICX104 is an implantable pellet.

Read more

It’s our formula in which we create this large pellet that’s subcutaneously implanted, and what that means is it goes into the fat area, the adipose tissue, usually in the lower right or left quadrant of the abdomen. And it’s a pellet that will just dissolve over weeks and months as a gradual release pellet so releasing therapeutic levels of naltrexone into the system until it completely dissolves. So that’s all BICX104 is at this time. It’s an implantable pellet that fits into the treatment hopefully one day fits into the treatment modalities, along with oral naltrexone and the once-a-month injectable naltrexone and then BICX104 aims to be that three-month implantable version of naltrexone.

How has the BICX104 research been funded?

All studies to date on BICX104 has been funded in most part by NIH and NIDA. NIH is the National Institutes of Health and NIDA is the National Institute on Drug Abuse. So we’re very proud of and thankful for that partnership with NIDA. To date they have funded us with approximately $9.2 million, which was which brought us, you know, through R&D, took us through preclinical, and into the clinical studies.

What are the next steps for BICX104?

BICX104 received its IND clearance from the FDA in 2021 and we are currently in our first human clinical trials of the product. So, it’s gone through pre-clinical studies, we received an IND, and we are now in the clinical phase in human subjects.