The Drug Delivery Company Receives 4th patent for Its Bio Absorbable Drug Delivery System, Moving it Closer to Its Goal of Helping to Slow the Opioid (Fentanyl) Overdose Crisis
SALISBURY, MD / ACCESSWIRE / January 4, 2022 / The Drug Delivery Company, LLC, a research and development company that specializes in breakthrough, innovative treatments for addiction and substance abuse disorders, announced that it was allowed its 4th patent for its drug delivery technology portfolio (USPTO # 11,197,819). This latest invention, “Extended Release Bio Absorbable Subcutaneous Medicinal Dosage Delivery Implant System”, is pivotal to the company’s long acting (6 month) bio absorbable naltrexone implant, which is targeting opioid use disorder. It is hoped that this implant will reduce the rising number of fentanyl and opioid overdose deaths.
In addition to the Covid 19 pandemic, 2021 will remembered for another tragic milestone – a new record for the most overdose deaths. Data from the CDC demonstrated that there was a 28.5% increase in drug overdose (fentanyl) deaths to 100,306 deaths during the 12-month period which ended in April 2021. https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm
The Drug Delivery Company (DDC), (Salisbury, MD), has developed a long-acting naltrexone implant that is implanted under the skin. Preliminary studies of this naltrexone implant have demonstrated that it can deliver adequate levels of naltrexone into the blood stream for up to 7-9 months. The higher doses of naltrexone released by the DDC implants were able to block “fentanyl-induced respiratory depression”, as compared to placebo implants in pre-clinical trials. Respiratory depression is what causes people to stop breathing after taking or injecting fentanyl. The “steady-state” release of naltrexone from the implant, eliminates an addict’s craving for opioids, increasing the likelihood that they will remain abstinent and in treatment.
“The implant is inserted during a minor procedure and provides protection against relapse or overdose for up to 6 months at a time.” said Dr. Jeffrey Benner. “We believe that it will save lives by preventing fentanyl overdoses.”
The implant is made from bio absorbable materials, that dissolve after the medication has been released. For that reason, it does not have to be removed. But, it can be easily exchanged for a new implant (every 6 months) for longer term treatments. It is made from well-tolerated, non-inflammatory materials (polymers). “Our early data is promising, but further studies are needed. We are applying to the FDA to request permission to begin trials in humans in 2022. We are very excited. This implant can reduce the number of unnecessary overdose deaths.” said Dr. Steven Cohen.
This project has been funded by the National Institute on Drug Addiction (NIDA), a subdivision of the National Institute of Health (NIH), as part of its Help End Addiction Long-term (HEAL) initiative.
There is an urgent need for treatment options that can delivery anti-addiction medications – without interruption – for longer periods of time. Francis Collins, MD, the outgoing director of the NIH, remarked that, “If we had a version of naltrexone that lasted for 6 months, that would be really, really powerful.” https://www.webmd.com/special-reports/opioids-pain/20180314/opioid-collins
With the current medical therapies, 50-66% of all opioid addicts drop out of treatment during the first year. Addiction experts consider the first year of abstinence to be an important milestone to reach when recovering from opioid addiction. If an addict can remain abstinent through one year, they are likely to make it. https://www.forbes.com/sites/sallysatel/2017/11/27/study-shows-two-addiction-medications-similar-but-drop-out-rates-high-three-possible-remedies/?sh=5e4e701d3884
One of the biggest barriers to treating opioid addiction or use disorder is medication compliance. Relapse, or a return to illicit opioid usage after opioid detoxification, occurs in up to 90% of patients, and is especially a problem for those being treated with medical assisted therapy. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5522736/ Traditionally, this approach involves replacing illicit opioids with safer legal opioids such as methadone or buprenorphine-naloxone (Suboxone). Daily usage is required to avoid going through opioid withdrawal. If discontinued, 50-90% of addicts will return to illicit opioid use. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5522736/
But Naltrexone is a different type of medical therapy. It is not an opioid. It is an opioid antagonist, and it is non-addictive. An opioid antagonist blocks an addict’s cravings for opioids. For this reason, a patient must be completely detoxified (for about 7-10 days) before starting naltrexone. If they are not detoxified, they will experience a severe withdrawal reaction. VivitrolTM is an extended-release version of naltrexone that is injected intramuscularly every 4 weeks. Vivitrol can help patients remain abstinent for longer than patients receiving supportive therapy alone. https://www.ncbi.nlm.nih.gov/books/NBK481477/ – :~:text=During the 24-week treatment,CI, 0.28 to 0.65),
Implantable extended-release naltrexone implants, with a lower dose of naltrexone, have been used in Australia and elsewhere for more than a decade. A 6-month Russian study eval found that 53% of those with naltrexone implant group remained abstinent, as compared to only 11% of the placebo group. Inflammation of the implant site was noted in some patients. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4014017/
The DDC implant was designed to release higher levels of naltrexone for a longer period and is made from well-tolerated polymers to minimize inflammation.
Drug Delivery Company is a Biotechnology start-up company that has been working in sustained-release drug delivery since 2014. It was founded in 2014 by Jeffrey. D. Benner, MD and Steven M. Cohen, MD.
Contact: For all inquires including investment opportunities, please contact: Steven M. Cohen, MD, scohen@rvaf.com, (727) 685-6632. Or visit our website : https://drugdeliverycompany.com/
Biographies:
Jeffrey D. Benner, MD is a co-founder and CEO of the Drug Delivery Company. He is a practicing physician and retinal specialist ophthalmologist who has been practicing at the Retina Consultants of Delmarva in Salisbury, MD since 1993. He is a graduate of the University of Maryland School of Medicine. He is an inventor who holds 10 patents. He can be reached at: jffbenner@gmail.com
Steven M. Cohen, MD is a co-founder and President of the Drug Delivery Company. He is a practicing physician and a retinal specialist ophthalmologist who has been practicing at Retina Vitreous Associates of Florida in St. Petersburg, FL since 1994. He is a graduate of Harvard Medical School. He is an inventor who holds 8 patents. He can be reached at: scohen@rvaf.com
SOURCE: The Drug Delivery Company
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