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Soin Therapeutics Obtains Orphan Drug Status from FDA for Low Dose Naltrexone to Treat Complex Regional Pain Syndrome


Soin Therapeutics, a pharmaceutical company based in Dayton, OH, was recently granted orphan drug status from the FDA for low dose naltrexone (LDN) to treat complex regional pain syndrome (CRPS).  

Soin Therapeutics is currently developing its unique formulation of low-dose naltrexone, which has several significant advantages over simple compounds. Of course, one of the most important aspects of LDN to treat CRPS is that it is non-habit forming, non-addictive, and will not sedate patients like other opioid based painkillers. LDN actually treats the mechanism of pain in CRPS.

Complex Regional Pain Syndrome and Pain

Complex Regional Pain Syndrome is a rare, orphan disease characterized by severe pain, usually starting in an extremity, and is associated with extreme swelling, limited range of motion, changes to the skin or bone structure, and debilitating pain. In 1983, the Orphan Drug Act incentivized drug companies to research and develop treatments for rare diseases.

The effects of the disease are incredibly disruptive, leaving sufferers unable to enjoy even the simplest things in life, like taking a walk. The pain is chronic and unbearable. Pain management doctors say it is a nervous system disorder that most physicians are unfamiliar with and cannot treat effectively. 

Dr. Soin, an interventional pain management doctor and founder/researcher at Soin Therapeutics states, “We are delighted to obtain orphan drug status from the FDA and look forward to running a large, multicenter, national clinical trial to test efficacy. Patients with CRPS have been suffering far too long without a viable treatment option; low dose naltrexone represents an opportunity to hopefully help these patients.” 

Naltrexone as a Medication

Because there is no known cure and a lack of practical treatment options available for CRPS, Dr. Soin began researching chemical compounds to treat the pain directly rather than masking symptoms with the use of addictive pain medications.

Naltrexone is a medication used to manage alcohol or opioid addiction by reducing cravings and highs associated with the substance. In anecdotal reports, Naltrexone has also alleviated symptoms stemming from CRPS at very low doses (approximately 1/10th the amount) of currently approved indications. When the dose of the drug is substantially lowered, the pharmacological effects change favorably to treat CRPS.

Dr. Soin explains that obtaining Orphan Status from the FDA is an essential milestone for Soin Therapeutics. “We look forward to running a large-scale clinical trial and eventually FDA approval to help patients suffering from CRPS.” 

According to Dr. Soin, “Low Dose Naltrexone has unique properties to specifically help the disease cascade of CRPS including attenuation of microglial cells involved in pain transmission, reduction of proinflammatory cytokines, antagonism of the Toll-like receptor 4 (TLR4), as well as stimulating the release of endorphins which are the body’s natural pain killers.

This drug seems very well suited to treat several specific mechanisms of the disease process present in CRPS patients. All those properties that I just mentioned would seemingly be quite helpful in CRPS patients. Best of all, this is a non-addicting and non-sedating drug that could be a new way to treat complex regional pain syndrome.”

If you or someone you know suffers from chronic pain, the best thing you can do is find an interventional pain management specialist. Go to the ASIPP website physician finder at ASIPP – American Society of Interventional Pain Physicians to find one near you. The goal is to offer alternatives that treat the actual disease itself and avoid the dangerous effects of painkillers that only mask symptoms. 

Email Amol Soin at [email protected]