A biotech start-up company may have an answer for the opioid crisis

Abstract:

The Drug Delivery Company (ddcmed.com), co-founded by Steven Cohen, MD of St. Petersburg, Florida and Jeffrey Benner, MD of Salisbury, MD, is developing a sustained-release naltrexone implant that is implanted under the skin. Preliminary studies of this novel naltrexone implant have demonstrated that it is well tolerated and can deliver adequate levels of naltrexone into the blood stream for up to 7-9 months. It may help to help slow the trajectory of the current opioid crisis. More than 84,000 people died from an overdose of opioids in 2020.

A biotech start-up company may have an answer for the opioid crisis

St. Petersburg, Florida (August 6, 2021) – A local medical doctor is co-founder and president of Drug Delivery Company, a small company that is developing a treatment that could make big inroads on the opioid crisis.
As if the Covid 19 pandemic was not bad enough, 2020 will remembered for another tragedy – setting a new record for the most overdose deaths. The number of overdose deaths increased by 30% to 93,000 deaths in the United States — with 84,000 attributed to synthetic opioids (fentanyl), heroin and other opioids, excluding methadone. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm

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 director of the NIH, believes 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
Even 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 for recover 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
The Drug Delivery Company (DDC), is developing a sustained-release naltrexone implant that is implanted under the skin. Preliminary studies of this novel naltrexone implant by DDC have demonstrated that it delivers adequate levels of naltrexone into the blood stream for 7-9 months. “This early data is exciting, but further studies are needed,” 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.

Implantable extended-release naltrexone implants, with a lower dose of naltrexone, have been used in Australia 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. Mild inflammation of the skin at the implant site was noted in 2-5% of the patients. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4014017/
The DDC implant was designed to deliver a substantially higher doses of naltrexone for at least 6 months. It is made from less inflammatory polymers and it is designed to be easily exchanged for a new implant (~ every 6 months). In preliminary studies, the higher levels of naltrexone released from the DDC was able to block fentanyl-induced respiratory depression, as compared to the placebo implants. Injected fentanyl causes people to stop breathing. This respiratory depression is responsible for the record number of overdose deaths.
“We are envisioning a day when an opioid addict will be able to have a naltrexone implant placed in a five-minute procedure that will protect them from relapse for 6 months at a time,” said Dr. Jeffrey Benner. “It may also save lives by preventing fentanyl overdose.”
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. A patient must be completely detoxified (for about 7-10 days) before starting naltrexone. If are not detoxified, they will experience a severe withdrawal reaction. Vivitrol 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),