Drug manufacturer to launch commercial version of ‘natural painkiller’ Palmitoylethanolamide (PEA)

A large U.S. pharmaceutical company is preparing to go to market with a mass-produced commercial version of a natural pain management supplement that compounding pharmacies in Australia have been providing to integrative doctors and their patients for many years – Palmitoylethanolamide, or PEA.

In November the drug manufacturer, Gencor, announced it had recently completed a double-blind, randomised, placebo-controlled study with 120 patients that found PEA was beneficial in the management of chronic pain and also unexpectedly showed promise in two other areas of health care. The study is currently undergoing peer review with the results due to be published in the coming months.

As reported by Nutritional Outlook, Gencor’s managing director R.V. Venkatesh said they were greatly encouraged by the study’s results.

“We achieved significant reduction on the WOMAC scale,” Mr Venkatesh said. The WOMAC scale is a set of standardised questionnaires that measures five items for pain, two for stiffness and 17 for functional limitation.

Gencor’s PEA study also suggested the supplement may help reduce anxiety as well as improve sleep quality. The early indicators for sleep improvement were so promising the company is now designing a sleep study to further investigate how PEA could be used in this area.

The company plans to market the product under that name Levagen.

What is Palmitoyletanolaminde (PEA)?

PEA is an endogenous fatty acid amide and it’s thought to work by binding itself to a particular receptor in the cell nucleus. This receptor is known as the peroxisome proliferator-activated receptor alpha and it regulates the gene networks that control pain and inflammation. By attaching itself to the receptor, scientists believe PEA ‘switches off’ the receptor’s ability to transmit pain.

Mr Venkatesh said PEA was unique from other painkillers in that it disseminates throughout the body and is also produced naturally by the body at the source of inflammation. “The uniqueness of PEA is that it’s an autacoid,” he said, “Autacoids are produced and used up locally in every tissue; it’s not just produced in one particular organ…it shuts off the source of the inflammation and the source of the pain.”

“It prevents the output of inflammatory cytokines and interleukins into your system, and because of this, the effects last longer because it acts on the cause, not on the symptoms.”

Unlike other chronic pain medications, no serious side-effects or adverse drug-drug interactions have been reported by users of PEA in early studies. PEA is found naturally in food such as eggs, milk, soy and peanuts and is also produced naturally in the body which may explain why no serious side effects have been reported to date – it may be that the body recognises and naturally assimilates the substance, however more research needs to be conducted to confirm this theory.

As it can be found naturally in common foods, in Australia Palmitoyletanolaminde is classified as a food substance and not a drug.

In a paper published in the Journal of Pain Research, Jan M Keppel Hesselink from the Institute for Neuropathic Pain in the Netherlands outlines several case studies where PEA significantly reduced the level of pain experienced by long-term chronic pain sufferers.

In the case of a 61 year old man suffering metastatic prostate cancer, PEA dramatically changed his quality of life. Before taking PEA his pain score was 7/10 on the numeric rating scale (NRS), on a good day, and 9/10 on a bad one. He was being treated for his chronic pain with the powerful painkillers, tramadol and pregabalin. After just 3 weeks of using PEA, he no longer needed to take tramadol and pregabalin and his NRS score had dropped to just 1-2.

For more information on PEA contact National Custom Compounding on 1300 731 755 or email admin@customcompounding. One of our friendly team will be able to put you in contact with an integrative doctor with experience in the use of PEA who will be able to advice on the best treatment for your individual condition.