Into the Big Leagues
Low dose naltrexone (LDN) is able to do for some people with intractable pain what opioids and other drugs can’t do – reduce the pain. Those drugs have something LDN doesn’t, however, – FDA approval.
You can’t prove that LDN works, however, until you can identify what you’re testing and with one compounding pharmacy producing it’s version of LDN and another producing it’s version of LDN – standardization – a key factor in any scientific analysis – has pretty much gone out the window.
Compounding LDN is not easy. A speaker at the recent LDN conference went through a surprising number of steps in the process that can go wrong. There are certainly good LDN compounding pharmacies, but the quality of preparation across all the pharmacies is clearly shaky.
If LDN is ever going to move from a niche product to a product that really makes a difference it’s got to be standardized.
Immune Therapeutics has been acquiring the patents, the orphan drug designation and getting the clinical data they need to get the LDN ball rolling at the FDA but until now they’ve been missing one critical factor: a pharmaceutical grade product.
Top Grade Compounding Company
“Our products are recognized as superior preparations due to our process validations that mirrors that of a pharmaceutical manufacturer. “KRS Global Biotechnology
How to produce that? By going to a compounding company that has such stringent processes that it provides compounded preparations of common drugs that are in short supply to hospital pharmacies. In this case, that means a company in Boca Raton, Florida named KRS Global Biotechnology.
KRS’s website is littered with claims touting the lengths they go to ensure the quality of their products. “Very few” compounding pharmacies in the nation, they state, can match their quality control. The rigor they employ is similar to that displayed by pharmaceutical drug companies. They provide certificates of analysis for all their preparations. They claim to be at the forefront of their industry and that’s apparently why Immune Therapeutics turned to them to produce what appears to be the first pharmaceutical grade LDN.
I don’t take LDN and am not familiar with its cost, but patients don’t appear to be sacrificing low cost for guaranteed quality. KSR is providing LDN at a dollar a pill in the following amounts: .5 mg., 1 mg., 1.5 mg., 3 mg. and 4.5 mg. I was informed that the most popular dose is easily 4.5 mg. and the 4.5 mg. tablets cost the same as the .5 mg tablets – one dollar.
This seems like a win-win situation. Patients get quality assurance for the LDN they buy and Immune Therapeutics has a product the FDA has stated they can use in clinical trials.
“This agreement with KRS Global will help people looking to purchase a formulated product while protecting Immune Therapeutics’ intellectual property. 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.” Seth Elliott, President and Chief Operating Officer of Immune Therapeutics
Immune Therapeutics is conducting some LDN trials in Africa, but the next big step is to start them in the U.S. with an eye to getting FDA approval. One way to support LDN development is to simply buy your LDN through KRS; Immune Therapeutics will use the funds derived from purchases at KRS to support their clinical trials.
Immune Therapeutics has the exclusive rights to develop LDN for a wide variety of disorders including Crohn’s Disease, IBS, prostate cancer, lymphomas, infectious diseases such as chronic herpes virus infections, Fibromyalgia, Parkinson, chronic infections due to the Epstein-Barr virus, and chronic inflammatory conditions including chronic fatigue syndrome. The most
The most likely targets for trials at this point are autoimmune disorders such as Crohn’s disease, rheumatoid arthritis and multiple sclerosis, as an adjunct treatment for cancer and as a complement to antibiotics in the treatment of infectious diseases. Cytocom, a spin-off company from Immune Therapeutics that is in charge of conducting clinical trials expects to begin Crohn’s trials this year.
To purchase LDN from KRS Biotechnology have your doctor send a prescription from his/her office to this fax number (561 989 1950). (The prescription must be sent from the doctor’s office.)
Looking for a doctor that knows about LDN? Check out Immune Therapeutic’s LDN prescribing doctor locator program here
Check out Health Rising’s LDN Resource Center for Fibromyalgia and Chronic Fatigue Syndrome
Health Rising is not associated with Immune Therapeutics or KSR Biotechnologies in any manner
Make sure you don’t miss another one by registering for our free ME/CFS and Fibromyalgia blogs here...
Tell us how your coronavirus vaccination went and find out how other people with ME/CFS and/or FM fared with their coronavirus vaccination in Health Rising’s Coronavirus Vaccine Side Effects Poll.