The US FDA (Food and Drug Administration) has granted Ohio-based pharmaceutical company Soin Therapeutics orphan drug status for low dose naltrexone (LDN) for the treatment of complex regional pain syndrome (CRPS). Complex Regional Pain Syndrome is characterized by severe pain and swelling, and is a rare disease that usually occurs in a limb or appendage of the body. Naltrexone has previously been used as a drug to treat patients with substance use disorders. At present, Soin Therapeutics is working on its own unique formulation of LDN and is planning to submit a pre-IND (Investigational New Drug application) to the FDA.
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