Milnacipran - the next wonder drug?
    by Karen Kaufmann MS, CCN, Phi Beta Kappa

Every once in a while, a new pharmaceutical drug appears that dramatically changes the medical approach to a particular illness. A good example of this is the antidepressant Prozac®.

Prozac was patented in 1977 and launched into the world marketplace in 1987. By the spring of 1990 Prozac had appeared on the cover of Newsweek, Time, and the New Yorker and was proclaimed the new “wonder drug,” as well as a powerful new weapon in the fight against depression.

Now another new drug- Milnacipran, may have an even greater impact on the market place. It is certainly positioned to improve the quality of life of a vast number of people.

According to the World Health Organization, 121 million people currently suffer from depression worldwide. An estimated 5.8% of men and 9.5% of women will experience a depressive episode in any given year. Equally as important, 2% to 4% of the population in industrialized nations suffer from one of a number of debilitating chronic pain syndromes including Fibromyalgia, Chronic Fatigue Syndrome, and Systemic Lupus Erythematosus (Lupus). These syndromes have challenged physicians and patients alike, since they are difficult to characterize and even more difficult to treat.

Lupus is a bit different because it is an autoimmune disease where the body has turned on itself. The person with Lupus can manufacture antibodies to over 116 different endogenous proteins and fight off these proteins as if they were foreign, dangerous viruses or bacteria.

Fibromyalgia and Chronic Fatigue are chronic pain illnesses which are characterized by widespread musculoskeletal aches, pains, stiffness, soft tissue tenderness, general fatigue, and sleep disturbances. Patients with Fibromyalgia or Chronic Fatigue experience a wide range of symptoms which may include headaches, migraines, impaired memory and concentration, dry eyes and mouth, vision problems, Raynaud’s phenomenon, and other neurological disturbances.

These illnesses are quite debilitating and present many unique challenges. The patient actually looks quite well and in most instances, the blood tests are normal. It is easy to assume this individual is not physically ill at all. The problem must all be “in his/her head” and a visit to the psychiatrist is in order. These syndromes have only recently been recognized. In fact, the experts still question whether Fibromyalgia and Chronic Fatigue are two different diseases, or just different presentations of the same disease. With the average patient waiting about 5 years for the correct diagnosis, the diagnosis of Fibromyalgia and Chronic Fatigue is often a diagnosis of exclusion.

The clinician must rule out other diseases and base their diagnosis on a number of clinical criteria defined by the American College of Rheumatology (ACR). There are still physicians who question whether Fibromyalgia and Chronic Fatigue are true disease entities. The patient is facing a host of baffling, invisible, unpredictable, painful, and exhausting symptoms and when he/she finally turns to the physician for help, answers do not come quickly. It is no wonder that chronic pain conditions such as Fibromyalgia , Chronic Fatigue, and Lupus share a number of clinical characteristics with depression.

Indeed, chronic pain can lead to depression and depression can cause chronic pain. I should point out however, that is quite possible to suffer the debilitating fatigue and widespread pain that so often accompany these conditions and experience no depression at all. The exciting fact is this new antidepressant Milnacipran, appears to be extremely useful in treating the most intractable aspects of all these syndromes and perhaps many more confusing, painful syndromes that are a part of life in the 21^st century.

Milnacipran is the first in a new class of antidepressants that are Norepinephrine Serotonin Reuptake Inhibitors (NSRIs). Milnacipran has an equal preference for norepinephrine and serotonin and it is clear that both norepinephrine and serotonin are involved in depression and chronic pain.

Since the early 1990’s the preferred pharmacologic treatment for depression has been the SSRIs such as Prozac and Paxil®. This is largely due to the improved tolerability of the SSRIs over the older antidepressants such as amitriptyline (Elavil®) which are tricyclic antidepressants (TCAs), although the SSRIs are not without side effects- the most notable side effect being sexual dysfunction.

Now for more than a decade, the treatment of depression has relied upon the single acting SSRIs, but in many ways, the SSRIs fall short. This is because moderate to severe depression is more effectively treated by the older Tricyclics because these agents target more than serotonin. The vast body of evidence now shows that drugs that increase serotonin alone, or norepinephrine alone, are equally effective in treating depression. However, norepinephrine is clearly more important in treating pain. Until recently, the most effective way to increase both norepinephrine and serotonin was through administering a Tricyclic.

The Tricyclics affect 6 different targets, and as a consequence, they have numerous side-effects including dry mouth, weight gain, drowsiness, fatigue, confusional states, disorientation, cardiac abnormalities and the list goes on. When you are suffering from a baffling, chronic illness and your major complaints are “brain fog,” pain and debilitating fatigue, the last thing you want to do is take a medication that can cause fatigue or confusion. Trust me, I can tell you this from my own personal experience. That is why Milnacipran is a potential lifeline for so many people. Unlike many drugs in its category, Milnacipran is NOT metabolized through the cytochrome p450 system. This means the medication is not likely to interact with other medications.  

On a personal level, I can tell you that I have been challenged by Lupus for the last 13 years.  Lupus is one of many autoimmune diseases that can cause widespread pain, extreme fatigue, and a host of other symptoms. Unlike Fibromyalgia and Chronic Fatigue; Lupus can be life-threatening, but it can also be quite mild, as it is in my case.  In Lupus your immune system can attack anything… any of the major organs including the kidneys, the heart, the lungs, the blood system and the brain. My special challenge has been the brain.  I have suffered from brain fog, cognitive dysfunction, and severe migraine syndromes. About 2 years ago I developed an extremely difficult neuropathic pain condition called trigeminal neuralgia, secondary to the Lupus. Trigeminal neuralgia is called the suicide disease and were it not for the medications I have gotten from IAS, I might have considered something that extreme.  I tried all the medications that are used to treat this disease including the anti-epileptic drugs such as Neurontin® and Topamax®.  In addition, I tried the Tricyclics. I could not tolerate the side effects of these medications. Eventually the pain became manageable with a regime of long acting and short acting opioids. Those drugs were the choice of last resort.

But now, for a little over 2 weeks I have begun taking Milnacipran (brand name Ixel®).  According to the clinical trials, one should begin to see the pain reduction benefit at about week number 8. I am happy to report I have already reduced my pain medication by one third and I remain completely hopeful that this reduction is just the beginning.

In addition, I seem to have much more energy. The phase II clinical trials in the US were recently completed and the results were amazingly positive. No one dropped out of the trial because of side effects, which is virtually unheard of.  Plus I have spoken to numerous rheumatologists who are involved in treating people with Fibromyalgia and Chronic Fatigue, and they just cannot wait until this medication is available.  As professionals they feel the previous therapies they have offered their patients have met with limited success.  It is wonderful that there is now a medication that promises to improve the quality of life of so many people.

Milnacipran may become the next wonder drug, and in a few years time be on the front covers of those well known public magazines I mentioned earlier, but remember you heard it here first!

ALL INFORMATION IS EDUCATIONAL AND SHOULD NOT REPLACE THE ADVICE OF YOUR PHYSICIAN.

The above  article is copyrighted and may not be copied without the written permission of International Antiaging Systems, Les Autelets  Suite A, Sark  GY9 0SF, Channel Islands, UK.

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