FDA Grants Orphan Drug Status to Soin Therapeutics for Low Dose Naltrexone (LDN) to Treat Complex Regional Pain Syndrome (CRPS)

DAYTON, Ohio, Sept. 9, 2021 /PRNewswire/ -- Soin Therapeutics, a pharmaceutical company based in Dayton, OH, was granted orphan drug status from the FDA for low dose naltrexone (LDN) to treat complex regional pain syndrome (CRPS).

Complex Regional Pain Syndrome is a rare, orphan disease that is characterized by severe pain, usually starting in an extremity, and associated with extreme swelling, limited range of motion, changes to skin or bone structure and debilitating pain.

Naltrexone is a medication that is primarily used to manage alcohol or opioid use disorder by reducing cravings or feelings of euphoria associated with substance use disorder. It has also been shown in anecdotal reports to alleviate symptoms stemming from CRPS at very low doses (approximately 1/10^th the dose) of currently approved indications. When the dose of the drug is substantially lowered, the pharmacological effects change favorably to treat CRPS.

"Obtaining Orphan Status from the FDA is an important milestone step for us at Soin Therapeutics. We look forward to running a large-scale clinical trial and eventually FDA approval to help patients suffering from CRPS", noted Dr. Amol Soin, the founder and CEO of Soin Therapeutics. Dr Soin, a practicing pain management physician, has seen firsthand the suffering that CRPS patients experience. CRPS is a disease without a cure and there is a lack of any viable treatments which led Soin to look deeper at LDN as a potential treatment.

"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 release of endorphins which are the body's natural pain killers. Basically, this drug seems very well suited to treat several mechanisms of the disease process. All those properties 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", Soin said.

Currently, Soin Therapeutics is developing its own novel formulation of LDN and is in the process of preparing a pre-IND (Investigational New Drug application) meeting with FDA as a needed step to commence a large, multicenter, national clinical trial.

About Soin Therapeutics: Soin Therapeutics Inc. (STI) is a pharmaceutical company founded by Dr. Amol Soin, a pain management physician from Dayton, OH. STI is currently developing low dose naltrexone to treat complex regional pain syndrome and has received an orphan drug designation from the FDA.

About Amol Soin: Dr. Amol Soin is a physician researcher and entrepreneur in the field of pain management. Currently, Soin is the president of ASIPP (American Society of Interventional Pain Physicians) and is in private practice. Dr. Soin has founded multiple biotech start-up companies, holds multiple patents and has published over 100 scholarly articles, abstracts, and textbook chapters in the field of pain management.

SOURCE Soin Therapeutics