Low dose naltrexone (LDN) is a hot topic among patients with multiple sclerosis (MS), cancer, neurological conditions, HIV infection, herpes, autism, and autoimmune diseases. With good reason. Clinical trials and anecdotal studies show that LDN can stop disease progression, reduce symptoms and help the body heal itself. And if that isn't enough, LDN is inexpensive and it's FDA approved. There's just one catch. Naltrexone hasn't yet been FDA approved for conditions other than opiate abuse, alcohol abuse and self-injurious behaviors. It can be prescribed off-label for other conditions but in this manner, LDN is kept out of the public eye.
However, because naltrexone has been a generic drug for more than a decade, pharmaceutical companies aren't interested in funding clinical trials for a drug they can't patent.
Naltrexone is an opiate antagonist developed in the early 1980s in response to the need for an effective treatment for opiate addiction. Its safety and effectiveness at doses ranging from 50 to 300 mg daily were confirmed in clinical trials. In 1984, the FDA approved naltrexone as a treatment for opiate abuse, and several years later it was approved as a treatment for alcohol abuse. In the protocol known as low dose naltrexone, naltrexone is used in doses ranging between 1.5 and 10 mg daily.
During the development phase of naltrexone, Dr. Ian Zagon and his team at Pennsylvania State University began researching naltrexone and other opiate antagonists. Dr. Zagon was particularly interested in the reasons for the low birth weight in children born to heroin addicts. His studies led to the discovery that opiate antagonists such as naltrexone and naloxone caused increased production of endorphins. He discovered that besides making us feel better, endorphins are neurotransmitters that regulate immune function and cell growth. Most importantly, he found that low doses of naltrexone blocked the opiate receptor intermittently and caused a dramatic increase in endorphins. Increased production of one particular endorphin, met-5-enkephalin, Dr. Zagon found, inhibited cell proliferation, reducing inflammation in autoimmune and neurological disorders and stopping cell growth in tumors.
Dr. Zagon published his findings around the same time naltrexone was introduced in clinical trials for drug abuse. Dr. Bernard Bihari in New York City took an immediate interest in Dr. Zagon's reports of the immune system effects of naltrexone. The reports of low dose naltrexone confirmed what he was seeing in drug addicts recently diagnosed with HIV infection. Individuals infected with HIV using naltrexone weren't progressing to AIDS as quickly. Seeing the potential for low dose naltrexone, Dr. Bihari began prescribing low doses of naltrexone to patients with multiple sclerosis and other immune-mediated illnesses who weren't responding to other therapies. Dr. Bihari's childhood friend, Dr. David Gluck started up a website www.lowdosenaltrexone.org/ where he shared news of LDN's success. Dr. Bihari began publishing reports of his findings to AIDS conferences and he organized the first LDN conference in New York City in the fall of 2005. In 2007, the National Institutes of Health showed their interest by hosting a conference on the unexplored potential of opiate antagonists.
It didn't take long for patients searching online, especially MS patients, to begin using low dose naltrexone. Worldwide, patients began demanding LDN and sought out physicians who would prescribe it. Sammy Jo Wilkinson and other patients with MS, who experienced dramatic improvement, began fundraisers and collected enough money to partially fund the first clinical trial of low dose naltrexone in humans at the University of California San Francisco in 2008. A similar trial in Italy proved LDN's potential in MS. Clinical trials of LDN in Crohn's disease and pancreatic cancer have shown early promising results at Pennsylvania State University. Dr. Zagon at Penn State has been studying LDN for more than 30 years and is pleased to see people worldwide benefiting from his efforts.
However, because naltrexone has been a generic drug for more than a decade, pharmaceutical companies aren't interested in funding clinical trials for a drug they can't patent. Clinical trials, such as the trials of LDN in fibromyalgia and Gulf War Syndrome Dr. Jarred Younger is conducting at Stanford University, are being funded by grants and private donors. Dr. Zagon relies on small grants and private donations for his ongoing research on LDN in MS and cancer. In the meantime, most patients who could benefit from LDN don't know it exists. And without glossy ads in medical journals from pharmaceutical companies, most doctors remain uninformed.
Elaine Moore and Samantha Wilkinson, The Promise of Low Dose Naltrexone Therapy: Potential Benefits in Cancer, Autoimmune, Neurological and Infectious Disorders, Jefferson, NC: McFarland and Company, Incorporated, 2008.
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