The History of Low Dose Naltrexone
Is it possible that Autoimmune Diseases, Multiple Sclerosis, Cancer, Neurodegenarative Disorders, Autism Spectrum Disorders, Wound Healing and Infections, Immune System and HIV/Aids can receive relief from an orphan drug? It's difficult to believe that there may be hope for people suffering from such a diverse array of conditions. Clinical trials have not yet proven the effectiveness of Low Dose Naltrexone (LDN), but lay trials by people desperate to find anything to reduce their symptoms, are leading more frequently to this old drug.Low Dose Naltrexone is Naltrexone given in substantially lower doses. The endorphin receptor blockage in the brain gives relief to a wide range of diseases and conditions. Often at the urging of their patients, more doctors are discovering the off-label uses for LDN and no longer resisting its use in the therapeutic regime. Off-label use is permitted by FDA and is a growing practice.
The history of Naltrexone is basic to understanding why it is showing success in the treatment of so many seemingly unrelated diseases and disorders. As with so many other drugs, the best use may not be the original use.
Naltrexone was developed by Endo Laboratories in 1963 with patent (Endo 1639A) following in 1967. The purpose of this newly synthesized drug was to block pleasure areas of the brain thereby and reducing the feeling of needing one more drink or one more 'hit' of narcotics. It was FDA approved for the treatment of alcohol and opiate abuse.
1969 saw the purchase of the small Long Island pharmaceutical company by DuPont. With the acquisition came many drugs developed by Endo and valuable expertise in drug manufacturing and marketing. Naltrexone was one of drugs DuPont acquired.
The late sixties saw a rapidly increasing need for treatment alternatives for alcohol and drug additions. This need was so great that the Federal government initiated the Special Action Office for Drug Abuse Prevention (SAODAP) in 1971 to improve treatment both institutionally and community-based. During this period, SOADAP realized that further development of Naltrexone would require governmental funding to bring it into the market.
Federal involvement with Naltrexone and DuPont continued as the Drug Abuse Office and Treatment Act was passed in 1972. Financial support for research of "long-lasting, non-addictive, blocking and antagonist drugs or other pharmacological substances for the treatment of heroin addition" resulted.
Clinical trials were initiated in 1973 as a treatment for heroin addiction. Laboratory animal trials demonstrated therapeutic levels to be non-toxic with very few side effects. Human trials proved to be a bumpy road.
It was a time of cultural revolution. And, part of that revolution included experimenting with addicting. Trying to locate trial participants proved to be very difficult. In order to become part of the treatment, it was discovered that patients had to be opiate-free for a minimum of five to ten days. If the patient was not opiate-free, severe withdrawal symptoms would occur.
Naltrexone had no reinforcement (high) or withdrawal when discontinued and required psychosocial support services. However, if the addict attempted opiate use in conjunction with Naltrexone, withdrawal symptoms would occur. Many participants opted for the use of Methadone to suppress cravings.
1984 saw FDA approval for Naltrexone in a 50mg dose for treatment of heroin addiction, DuPont brand-named the drug Trexan, and DuPont's Naltrexone patent expired.
In 1985, FDA designated Naltrexone as an orphan drug. This provided DuPont with seven additional years exclusivity with Naltrexone.
That same year, Philadelphia's Veterans Administration Center began a study on the effectiveness of Naltrexone in alcohol abuse without benefit of outside funding. This was perhaps the first study of treating alcohol abuse with medication. The promising results led to further testing.
Yale University School of Medicine tested in 1991 in conjunction with psychological therapy with the result of nearly twice the success rate as placebo use.
After clinical trials, the FDA approved Naltrexone in a 50mg dose as treatment for alcohol abuse. At this time, DuPont changed the name to ReVia.
Another stumbling block was insurance company acceptance. Some would not cover the drug unless it was dispensed by specialists or treatment facilities. Others would not accept the drug at all.
Resistance by physicians and insurance aided the drug following out of favor. The fact that it worked and had virtually no side affects was not the issue. Poor sales resulted and halted phase IV clinical trials.
Naltrexone (Trexan/ReVia) was eligible for generic production when the exclusivity agreement lapsed in 1997. The gauntlet has been picked up by several drug companies around the world.
Hope for Low Dose Naltrexone (LDN) use may be with the FDA Orphan Drug Program. With this status, qualifying products may be eligible for a portion of development costs.
At this time, word of mouth seems to be the best way to spread the word about LDN. Thousands are experiencing relief from this inexpensive, generic immune modulator. And, no known harmful side effects. What more could you ask?