Why hasn’t LDN been approved by the FDA for MS?
Naltrexone (in the higher 50mg dosage) was approved by the FDA in 1984 for opiate abuse therapy, and again in 1995 for alcohol addiction. Its safety and efficacy have been proven in clinical trials. In the much lower dosage of 3 or 4.5mg, Naltrexone has not yet been submitted for FDA approval. Federal regulations prevent the FDA from approving LDN as an MS therapy until it undergoes specific clinical trials for MS.
