Low Dose Naltrexone
FDA-approved naltrexone, in a low dose, can normalize the immune system — helping those with HIV/AIDS, cancer, autoimmune diseases, and central nervous system disorders.
LDN Editor’s Blog
Further Good News from TNI Biotech — June 2013
In addition to patents and licenses, TNI BioTech has obtained the rights to the clinical data and the transfer of the Investigational New Drug (IND) and orphan drug designations from the U.S. Food & Drug Administration for pancreatic cancer and Crohn's disease.
TNI Biotech believes the orphan drug designations will allow the company to fast track the development of clinical trials for both of these indications in the United States and internationally [utilizing either Met-enkephalin (“MENK”) and/or low dose naltrexone (“LDN”)].
The Form 10 document, financial statements, auditor's footnotes, and opinion letter can be found on the company's website.
Welcome to the Low Dose Naltrexone (LDN) Home Page
Updated: June 9, 2013
The authors of this website do not profit from the sale of low-dose naltrexone or from website traffic, and are in no way associated with any pharmaceutical manufacturer or pharmacy.
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“Low Dose Naltrexone (LDN) may well be the most important therapeutic breakthrough in over fifty years. It provides a new, safe and inexpensive method of medical treatment by mobilizing the natural defenses of one’s own immune system.
Latest Results from Clinical Trials of LDN
Around the globe, there has been a quantum leap forward in the number of ongoing research studies on LDN.
Latest developments include:
Click this box for details on all clinical trials of LDN.
LDN Website Contents
> On this page you can find answers to these questions:
> You can go to more detailed information on these linked pages:
ABC News Reports:
Other Autoimmune Diseases:
Cancer. As of mid-2004, Dr. Bihari reported having treated over 300 patients who had a cancer that had failed to respond to standard treatments. Of that group, some 50%, after four to six months treatment with LDN, began to demonstrate a halt in cancer growth and, of those, over one-third have shown objective signs of tumor shrinkage.
Autoimmune diseases. Within the group of patients who presented with an autoimmune disease (see above list), none have failed to respond to LDN; all have experienced a halt in progression of their illness. In many patients there was a marked remission in signs and symptoms of the disease. The greatest number of patients within the autoimmune group are people with multiple sclerosis, of whom there were some 400 in Dr. Bihari's practice. Less than 1% of these patients has ever experienced a fresh attack of MS while they maintained their regular LDN nightly therapy.
HIV/AIDS. As of September 2003, Dr. Bihari had been treating 350 AIDS patients using LDN in conjunction with accepted AIDS therapies. Over the prior 7 years over 85% of these patients showed no detectable levels of the HIV virus — a much higher success rate than most current AIDS treatments, and with no significant side effects. It is also worth noting that many HIV/AIDS patients have been living symptom-free for years taking only LDN with no other medications.
Central Nervous System disorders. Anecdotal reports continue to be received concerning beneficial effects of LDN on the course of Parkinson’s disease, Alzheimer’s disease, amyotrophic lateral sclerosis (ALS—Lou Gehrig’s disease), and primary lateral sclerosis. Dr. Jaquelyn McCandless has found a very positive effect of LDN, in appropriately reduced dosage and applied as a transdermal cream, in children with autism.
The disorders listed above all share a particular feature: in all of them, the immune system plays a central role. Low blood levels of endorphins are generally present, contributing to the disease-associated immune deficiencies.
Research by others — on neuropeptide receptors expressed by various human tumors — has found opioid receptors in many types of cancer:
These findings suggest the possibility for a beneficial LDN effect in a wide variety of common cancers.
Naltrexone is a prescription drug, so your physician would have to give you a prescription after deciding that LDN appears appropriate for you.
Naltrexone in the large 50mg size, originally manufactured by DuPont under the brand name ReVia, is now sold by Mallinckrodt as Depade and by Barr Laboratories under the generic name naltrexone.
LDN prescriptions are now being filled by hundreds of local pharmacies, as well as by some mail-order pharmacies, around the US. Some pharmacists have been grinding up the 50mg tablets of naltrexone to prepare the 4.5mg capsules of LDN; others use naltrexone, purchased as a pure powder, from a primary manufacturer.
One of the first pharmacies to compound LDN was Irmat Pharmacy in Manhattan. Their recent price for a one-month's supply of 4.5mg LDN (30 capsules) was $38. Irmat does monthly quality control testing on its LDN, accepts prescriptions from any licensed physician, checks for insurance coverage, and includes shipment anywhere in the US or to other countries. In contrast, Gideon’s Drugs charges only $15 for a one month’s supply of 4.5mg LDN but it does not accept insurance and it will charge for shipment.
|Irmat Pharmacy, New York, NY||(212) 685-0500|
|Gideon's Drugs, New York, NY||(212) 575-6868||(212) 575-6334|
|Belmar Pharmacy, Lakewood, CO||(800) 525-9473||(866) 415-2923|
|The Compounder Pharmacy, Aurora, IL||(630) 859-0333|
|The Pharmacy Shop and
Compounding Center, Canandaigua, NY
|McGuff Compounding Pharmacy,
Santa Ana, CA
|Skip's Pharmacy, Boca Raton, FL||(561) 218-0111|
|Smith's Pharmacy, Toronto, Canada||(416) 488-2600|
|Dickson Chemist, Glasgow, Scotland||+44-141-647-8032|
Reports have been received from patients that their pharmacies have been supplying a slow-release form of naltrexone. Pharmacies should be instructed NOT to provide LDN in an "SR" or slow-release or timed-release form. Unless the low dose of naltrexone is in an unaltered form, which permits it to reach a prompt "spike" in the blood stream, its therapeutic effects may be inhibited.
Fillers. Capsules of LDN necessarily contain a substantial percentage of neutral inactive filler. Experiments by the compounding pharmacist, Dr. Skip Lenz, have demonstrated that the use of calcium carbonate as a filler will interfere with absorption of the LDN capsule. Therefore, it is suggested that calcium carbonate filler not be employed in compounding LDN capsules. He recommends either Avicel, lactose (if lactose intolerance is not a problem), or sucrose fillers as useful fast-release fillers.
The FDA has found a significant error rate in compounded prescriptions produced at randomly selected pharmacies. Dr. Bihari has reported seeing adverse effects from this problem. Please see our report, Reliability Problem With Compounding Pharmacies. Please see the above list of recommended pharmacies for some suggested sources.
The usual adult dosage is 4.5mg taken once daily at night. Because of the rhythms of the body's production of master hormones, LDN is best taken between 9pm and 3am. Most patients take it at bedtime.
Rarely, the naltrexone may need to be purchased as a solution — in distilled water — with 1mg per ml dispensed with a 5ml medicine dropper. If LDN is used in a liquid form, it is important to keep it refrigerated.
The therapeutic dosage range for LDN is from 1.5mg to 4.5mg every night. Dosages below this range are likely to have no effect at all, and dosages above this range are likely to block endorphins for too long a period of time and interfere with its effectiveness.
LDN has virtually no side effects. Occasionally, during the first week's use of LDN, patients may complain of some difficulty sleeping. This rarely persists after the first week. Should it do so, dosage can be reduced from 4.5mg to 3mg nightly.
The FDA approved naltrexone at the 50mg dosage in 1984. LDN (in the 3mg or 4.5mg dosage) has not yet been submitted for approval because the prospective clinical trials that are required for FDA approval need to be funded at the cost of many millions of dollars.
The successful results of the first US medical center research on LDN, an open-label trial that tested the use of LDN in Crohn’s disease (details here), was presented in May 2006 by Professor Jill Smith of the Pennsylvania State University College of Medicine. The National Institutes of Health has granted $500,000 for Dr. Smith's group to continue the study as a larger placebo-controlled scientific trial of LDN in Crohn's disease.
All physicians understand that appropriate off-label use of an already FDA-approved medication such as naltrexone is perfectly ethical and legal. Because naltrexone itself has already passed animal toxicity studies, one could expect that once testing is able to begin, LDN could complete its clinical trials in humans and receive FDA approval for one or more uses within two to four years.
If you are suffering from HIV/AIDS, cancer, or an autoimmune disease, LDN could help. In AIDS and cancer therapy, LDN is often used in conjunction with other medications.
Cancer. Anyone with cancer or a pre-cancerous condition should consider LDN. Many use LDN as a preventive treatment. Post-treatment, others have been using LDN to prevent a recurrence of their cancer. LDN has been shown in many cases to work with virtually incurable cancers such as neuroblastoma, multiple myeloma, and pancreatic cancer.
HIV/AIDS. As an AIDS drug, LDN leads to far fewer side effects than the standard "AIDS cocktail." When used in conjunction with HAART therapies, LDN can boost T-cell populations, prevent disfiguring lipodystrophy, and lower rates of treatment failure.
Do not be afraid to approach your doctors — physicians today are increasingly open to learning about new therapies in development. Tell your doctors about this website, or print out and hand them the information, and let them weigh the evidence.
If someone you know has HIV/AIDS, cancer, an autoimmune disease, or one of the aforementioned central nervous system disorders, LDN could save them from a great deal of suffering. If they use e-mail, send them the address of this website (www.lowdosenaltrexone.org). Or, print out the site and mail them the information.
Low-dose naltrexone has the potential to reduce the terrible human loss now taking place throughout the globe. It is a drug that could prevent millions of children from becoming AIDS orphans. It is a drug that could be a powerful ally in the war against cancer.
If you or someone you know has connections in the media, the medical community, or to those in developing countries involved in AIDS policy or treatment, please let them know about LDN.
This website is sponsored by Advocates For Therapeutic Immunology. The purpose of this website is to provide information to patients and physicians about important therapeutic breakthroughs in advanced medical immunology. The authors of this site do not profit from the sale of low-dose naltrexone or from website traffic, and are in no way associated with any pharmaceutical manufacturer or pharmacy.
This website is not intended as a substitute for professional medical help or advice. A physician should always be consulted for any medical condition.
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Please note that no response can be given to individual questions concerning medical symptoms or treatment.