Immune Therapeutics, Inc. has signed an agreement with KRS Global Biotechnology, Inc., to collaborate on compounding, packaging and distributing the drug naltrexone, which is indicated for the treatment of several diseases, including rheumatoid arthritis, as announced in a press release. Immune Therapeutics holds the exclusive propriety and legal rights for Low Dose Naltrexone and the tablets are going to be compounded for shipment in the US.
KRS Global is a 503B outsourcing facility endorsed by the U.S. Food and Drug Administration (FDA), which according to the agreement, is expected to compound naltrexone tablets in several strengths, following a medical prescription. Low doses of naltrexone have been approved in the USA by the FDA for the normalization of the immune system, after being originally used to treat alcohol and drug dependencies.
“This agreement with KRS Global will help people looking to purchase a formulated product while protecting Immune Therapeutics’ intellectual property,” said the president and chief operating officer of Immune Therapeutics, Seth Elliott. We expect that the payments to Immune Therapeutics under the agreement with KRS Global will allow the company to provide funds to Cytocom Inc. so they can complete clinical trials with the FDA for Low Dose Naltrexone in Crohn’s Disease, MS, HIV/AIDS, in addition to other indications.”
In addition to rheumatoid arthritis, Low Dose Naltrexone is expected to also treat Crohn’s Disease, IBS and inflammatory diseases, prostate cancer, lymph proliferative syndrome, including malignant lymphoma, chronic lymphocytic leukemia, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma, but also infectious diseases like chronic herpes virus infections, chronic genital herpes, type 2 Fibromyalgia, Parkinson, chronic infections due to the Epstein-Barr virus, and chronic inflammatory conditions such as chronic fatigue syndrome.
Low dose naltrexone is also becoming a more common choice among physicians and patients. The drug has been proven effective in decreasing symptom severity, according to a study entitled “The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain” presented last year, in which the authors noted that the effects may be unique to low dosages of naltrexone and entirely independent from naltrexone’s better-known activity on opioid receptors.