-         The U.S. Food and Drug Administration –

People suffering from fibromyalgia, a common painful condition with the unknown cause, received the first treatment option, approved by the Food and Drug Administration for reducing pain, associated with this specific disorder. Lyrica (pregabalin), made by Pfizer, is now allowed and officially approved for reducing fibromyalgia symptoms.

"Today's new approval marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief with Lyrica," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research in the official press-release, issued by the FDA. "However, consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder."

The approval of Lyrica was based on the results, received during two double-blind, controlled clinical trials. About 1800 patients, suffering from fibromyalgia, were treated with doses of 300 or 450 milligrams of Lyrica per day. The trials showed that Lyrica can reduce pain and improve daily functions for some of those patients, who participated in the trial. At the same time, the FDA noted in its press-release that Lyrica should not be treated as a cure for fibromyalgia because not all people could benefit from the use of this medication.

Lyrica is a specific type of pain-relieving medications, which was designed to target a specific type of pain, known as nerve pain. The most common examples of nerve pain are diabetic nerve pain and pain after shingles. Lyrica was earlier approved for treating those types of pain. Now the FDA added fibromyalgia to the list of conditions, which can be treated with Lyrica.

Lyrica is also known as anticonvulsant for its ability to slow down the electrical signals, which are sent from nerves in the human body.

This medication should be used strictly in accordance with the doctor’s prescription. Lyrica should not be used by people planning a baby, because it may be harmful even for an unborn baby.

During the trials of Lyrica use for fibromylgia treatment, the most common side effects were mild-to-moderate dizziness, sleepiness, blurred vision, weight gain, dry mouth, and swelling of the hands and feet.  

Fibromyalgia is a common condition, affecting about 3 to 6 million of people in the USA each year. It is long-lasting or chronic pain in the fibrous tissues deep in the muscles. The pain is often accompanied with fatigue and headache. One of the specific signs of fibromyalgia is that a person suffering from it usually has about 11 – 18 “tender points” – areas on the body, which become painful when pressed.

It should be noted that this condition has been recognized by medicine only since the early 1980^th, and it is not known for the time being what exactly causes fibromyalgia. Doctor Muhammad B. Yunus, who is considered to be the father of modern view of fibromyalgia, says that this condition belongs to the so-called central sensitivity syndromes (irritable bowel syndrome, migraines and restless leg syndrome are also examples of CSS). Dr. Yunus associates fibromyalgia with the central sensitization, where the central nervous system (spinal cord and brain) becomes so much sensitized on certain parts of the body, that even mild pressure or touch would cause intense pain.

Till now the condition remained untreated in most cases, sometimes common pain killers, such as NSAIDs, were used to relieve the pain. The approval of Lyrica by the FDA can probably be treated as a signal for all pharmaceutical companies, which aims at showing the necessity to develop an effective medication, designed to treat such a specific type of pain as that associated with fibromyalgia.

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External resources
http://www.amazon.com/American-Medical-Association-Complete-Encyclopedia/dp/0...
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01656.html
http://www.sciencedaily.com/releases/2007/06/070625095756.htm
http://www.drugs.com/lyrica.html
http://www.lyrica.com/

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