Tuesday, July 30, 2013

Low Dose Naltrexone for Crohn's: The No-Brainer Case For The FDA

         
           (This picture is of a colonscopy of a before and after of a Crohn's patient who took LDN)

So in a prior post I discussed low dose naltrexone (LDN). LDN was first introduced in 1984 for people with alcohol dependence. The drug has been shown to reduce the relapse rates. What inspired me to write this post was I saw this recent story that talked about how drug company TNI BioTech met with the FDA and Phase III trials may start as early as first quarter in 2014.

The evidence for low dose naltrexone is pretty convincing in terms of being both effective and safer than the current alternativies of Humira, Remicade, and other drugs. This land mark study from Dr. Jill Smith at Penn State University showed that 67% of people went into remission. 89% of patients showed a clinical response which is similar to the rates of Humira and Remicade (however the only real side effects with LDN is vivid dreams and fatigue). In 2011, this study was done by Smith and her colleagues which found that 78% of patients showed an endoscopic response. 88% of patients who took the LDN showed a 70 point decline in their CDAI score (which is a significant decrease). The only side effect was fatigue.

A recent study from April 2013 in children showed that low dose naltrexone was safe and showed reduced activity for Crohn’s patients. However, only 25% of children (between 8-17 years of age) went into remission, however 67% showed improvement. Here is a case study of a 14 year old girl who had Crohn's and pain for 3 years. After a month of taking 4.5 mg of low dose naltrexone she improved. An EGD (esophagogastroduodenoscopy) showed complete muscoal healing and normal biopsies which is quite impressive.

LDN has been shown to be useful in other treatments like multiple sclerosis, prolonging the live of pancreatic cancer patients, and may even help people with HIV and AIDS. There is no question some more studies have to be done on what LDN can exactly help.

Why on earth is this drug still not approved for Crohn's? I would suggest the FDA talk to patients with Crohn's and see how they currently feel given the current state of options in the Crohn's world. Low dose naltrexone seems to show help patients with minimal side effects compared to Humira, Remicade, Enbrel, 6-MP and any other drugs you want to compare it to. The initial study for LDN on Crohn's was done in 2007. So why is it taking 7 years to now just get around to a Phase III trial? 

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