Soin Therapeutics, based in Dayton, OH, has been granted orphan drug status by the FDA for low dose naltrexone (LDN) to treat complex regional pain syndrome (CRPS).
This is a game changer step for CRPS which is one of the most overlooked rare disease states. CRPS is known for severe pain along with extreme swelling, limited range of motion, changes to the skin or bone structure, and debilitating pain.
Soin Therapeutics’ LDN can potentially help people living with CRPS alleviate pain and avoid addictive medications (which is mostly the norm currently).
Where did the development of LDN start from?
CRPS is an orphan disease (as classified by National Organization of Rare Diseases (NORD)) and these diseases are neglected mainly because of the cost associated with developing new treatments.
Orphan diseases affect less than 200,000 Americans, which is why there are such a small number of treatment options available. There is no cure yet for CRPS and only a few practical treatment options, none of which are specific to treating the exact disease.
This situation is what prompted Dr. Amol Soin to research and work on finding a non-addictive and reliable treatment option for CRPS.
Dr. Soin, a pain management physician, inventor, and researcher, works on developing new non-addictive and non-opioid treatments for chronic pain. Masking the symptoms of chronic and severe pain has been the norm, but Soin Therapeutics’ LDN is about to change that for the good.
The orphan drug status by the FDA gives Soin Therapeutics market exclusivity and other benefits which help make this a viable option.
How is LDN different from the current available treatments?
Naltrexone is a medication usually used to help people manage alcohol or opioid addiction. The way Naltrexone works is by reducing the highs and cravings linked to opioid and alcohol.
The interesting thing is that Naltrexone can relieve CRPS symptoms (as per Anecdotal reports) at very low doses (approximately 1/10th the dose) of currently approved indications. At these low doses, the chemical interaction is very different which may benefit CRPS by stimulating the bodies natural pain killers called endorphins while also having an effect on cells called microglia that are involved in the pain cascade associated with CRPS. “In addition to the microglial cell attenuation and endogenous endorphin effect, LDN has many benefits specific to CRPS by it’s action on interleukins which are chemicals specifically elevated in these patients.”, noted Dr Amol Soin.
Soin Therapeutics has completed a novel formulation of the drug. It is revolutionary when compared to current available treatment options, especially in the way it is delivered and absorbed.
It is a single oral pill taken at night which is effortless for everyone.
How the Opioid Crisis prompted Dr. Soin to work on finding a solution?
Here is what Dr. Soin says about the motivation behind him starting the research on a treatment for CRPS, “About 10 years ago – I realized we were in the midst of an opioid crisis. More people in Ohio were dying of drug overdoses than car accidents. Drug overdose became the most likely cause of death for younger people. I knew we had to act. We had to find new ways to manage pain without addicting pain killers. Thus I started researching ways to treat pain. This led me to invent new therapies and attempt to treat pain without addiction.”
In fact, Opioid overdose deaths per CDC increased to 75,673 in the 12 month period ending in April 2021 up from 56,064 the year before. From 1964 – 1975, 47,434 Americans were killed in the Vietnam war, so Opioid deaths even outpace that number per year.
Who is Dr. Amol Soin?
Amol Soin is an interventional pain management physician from Dayton, OH who has 5 college degrees (2 from Ivy League Schools), is politically active (serving on the Ohio medical board appointed to two, 5-year terms by Governor Kasich) and is also the current president of the American Society of Interventional Pain Physicians (ASIPP).
Pictured Above is Dr Amol Soin, MD in his research laboratory
ASIPP is one of the largest organizations for pain management physicians in the USA.
He is a medical researcher who has invented multiple new drugs and medical devices to treat pain without addiction and an entrepreneur who has founded multiple startup companies based on his research which have grown to disrupt the medical industry in a positive way.
What happens next?
Dr. Soin and the team at Soin Therapeutics have completed the development of the new formulation. They will be having a meeting with the FDA during the 3rd quarter of 2022 to plan large-scale multicenter pivotal trials to facilitate the FDA approval.
After the approval, life is not going to be the same for people suffering from CRPS. LDN will hopefully help people alleviate pain that has been troubling them for years.
