Because Ned Said: New Technology Helps Prevent Opioid Overdose

There has been quite a bit of talk in recent decades about opioid use disorder. It becomes very difficult to keep folks intent on abusing such substances from accidentally overdosing on them. Or, as FDA officials like to call it, “multiple tablet ingestion”—I guess it sounds better to them. But the end result is the same: The person has caused themselves harm in a way that may cause them injury and even end their life abruptly.

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Although opioid therapy has been a part of chronic pain management for years and is viewed as indispensable in multiple clinical situations, in many instances, the risks of addiction and overdose with the use of opioid therapy clearly can outweigh the benefits. According to the US Congress Joint Economic Committee, the financial drain on the economy due to drug overdoses was nearing an alarming toll of $1.5 trillion (about $4600 per capita in the US) in 2020.¹ And the scale of this crisis to the lives and families affected is even more devastating, taking into account the socioeconomic drain on their daily lives, not to mention the emotional toll.

However, a new advancement in the marketplace is intended to prevent potential injury or death. Abuse Deterrent Pharma, LLC (ADP), has licensed the LIMITX technology from Acura Pharmaceuticals for a number of pharmaceutical compounds. ADP and Acura Pharmaceuticals jointly conducted years of research in LIMITX, an investigational technological drug delivery product, with the hopes of playing a critical role in mitigating elevated maximum concentration levels of certain drugs that have plagued communities for years. This research has mainly been focused on the formulation that contains the combination of hydrocodone and acetaminophen.²

The LIMITX technology is designed to strategically control the release of the drug in vivo utilizing a precise buffer in the tablet matrix with microparticles that contain the active drug and an acid soluble ingredient. The manufacturing process utilizes hot melt extrusion (HME) for microparticle manufacturing. HME in drug manufacturing typically employs corotated twin extruders and uses heat and pressure to create solid dosage forms, dispersing the active pharmaceutical ingredient within a molten polymer matrix, and forming a solid solution or amorphous solid dispersion. It has been used frequently for manufacturing poorly soluble compounds.³

Now, bringing you back to your pharmacy school pharmacokinetics lecture hall, consider this: The unique profile of LIMITX, in particular the combination of hydrocodone and acetaminophen, works by reducing the maximum concentration of hydrocodone in the blood after multiple doses are administered. With the use of this innovative technology, if the user increases the intake of hydrocodone tablets, whether accidentally or intentionally, doing so adds more buffer to the stomach, which causes the gastric pH to increase. As the gastric pH increases, the release of the drug slows significantly, resulting in lower blood peak levels of hydrocodone. In essence, increasing the number of hydrocodone tablets in this instance adds more buffer to the stomach and gastric pH increases. The hypothesis behind the LIMITX technology was backed by a recent pharmacokinetic study involving healthy fasted adults. In this study, participants experienced maximum concentration level reductions of up to 30% when exposed to higher buffer ingredient levels.⁴

Although the ingestion of such a prepared medication may not change the habits of the individual, it certainly would be a deterrent if the FDA authorized this formulation in more drugs introduced into the marketplace. It just might start saving lives.

REFERENCES

1. The economic toll of the opioid crisis reached nearly $1.5 trillion in 2020. Joint Economic Committee. September 28, 2022. Accessed May 27, 2025. https://www.jec.senate.gov/public/index.cfm/democrats/2022/9/the-economic-toll-of-theopioid-crisis-reached-nearly-1-5-trillion-in-2020

2. Acura Pharmaceuticals, Inc. and Abuse Deterrent Pharma, LLC announces second meeting with US Food and Drug Administration. MarketScreener. May 21, 2025. Accessed May 27, 2025. https://www.marketscreener.com/quote/stock/ACURA-PHARMACEUTICALS-INC-120789192/news/Acura-Pharmaceuticals-Inc-and-Abuse-Deterrent-Pharma-LLC-Announces-Second-Meeting-with-USFood-an-50051868/

3. Acura Pharmaceuticals engages Catalent Pharma Solutions to advance development of LTX-03. News release. FirstWord Pharma. September 9, 2019. Accessed May 27, 2025. https://firstwordpharma.com/story/4855075

4. Acura Pharmaceuticals, Inc. Form 8-K. US Securities and Exchange Commission; 2025. Accessed May 27, 2025. https://www.sec.gov/Archives/edgar/data/786947/000110465925051289/tm2515724d1_8k.htm