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News & Announcements: 2005 |
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LYRICA® (Pregabalin) to Launch in US in SeptemberLyrica® (pregabalin), Pfizer's new drug to treat nerve pain caused by diabetic neuropathy and postherpetic neuralgia (shingles), will be available by prescription in the United States in September. The expected launch date is September 12, 2005. Lyrica® is seen as Pfizer's successor to Neurontin® (gabapentin) - a widely prescribed and very successful epilepsy drug that has been used to treat other conditions, including diabetic neuropathy. Diabetic peripheral neuropathy, the most common complication of diabetes, affects more than 60 percent of diabetics. The pain of diabetic neuropathy is often described as burning, tingling, stabbing and shooting pain in the feet, legs, hands or arms. Postherpetic neuralgia, a complication of shingles (herpes zoster), is a painful outbreak of rash or blisters on the skin, caused by the reactivation of the same virus that causes chicken pox. The pain in the area of the rash is often described as constant stabbing, burning, or electric shock-like sensations. According to Pfizer, Lyrica® has a newly defined mechanism of action. More than 9,000 patients participated in six double-blind, placebo-controlled trials of the new medication. The most common side effects reported by patients i ncluded dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of hands and feet, and dry mouth. For more complete information, please read the full Prescribing Information and Patient Information and talk to your doctor. Pfizer received approval in December 2004 from the US Food and Drug Administration to market Lyrica ® for the management of neuropathic pain associated with diabetes and postherpetic neuralgia; several months later it was approved for the treatment of partial-onset seizures in adults with epilepsy. However, the launch was delayed while the new drug underwent controlled-substance scheduling at the Drug Enforcement Administration. Lyrica® is now classified as a controlled substance with the lowest potential for misuse or abuse under Schedule V. This category includes cough suppressants containing small amounts of codeine. New Gene for Charcot-Marie-Tooth DiseaseCharcot-Marie-Tooth disease (CMT), a progressive, inherited neurological disorder that affects the peripheral nerves, comes in several forms. It is caused by mutations in genes that produce proteins involved in the structure and function of either the peripheral nerve axon or the myelin sheath. The autosomal dominant intermediate form of CMT has previously been linked to genes located on chromosome 19. In a recent study published in Nature Genetics, an international team of researchers identified the responsible gene as Dynamin 2 (DNM2), whose protein helps cell membranes fuse together and separate. The mutation, found in several families from North America, Australia, and Belgium, impairs a variety of critical cell transport processes. In addition, neutropenia, a white blood cell disorder, was found to be inherited along with the disease, which has not been seen in CMT families before. The same protein function that is impaired by the mutation – the ability to bind a high-energy molecule called CTP – is also impaired by other CMT gene mutations, suggesting this may be a central pathway for a large class of peripheral neuropathies. To read more about the study, click on Mutations in the Pleckstrin Homology Domain of Dynamin 2 Cause Dominant Intermediate Charcot-Marie-Tooth Disease: LBS.002. Creepy-Crawly, Crazy Legs - Restless Leg Syndrome
Restless leg syndrome (RLS) is a common neurological disorder that may affect 10 percent of the population, but has long been ignored or misdiagnosed. People with restless leg syndrome have an uncontrollable urge to move their legs, along with uncomfortable or painful feelings in the legs or calves (and sometimes the arms or other parts of the body). The troubling sensations are described as creepy-crawly, crazy legs, pins and needles, like soda bubbling in the veins, or like an electric current. Restless leg syndrome affects both men and women and can start at any age, but is more common and more severe among older people. For most people, the symptoms are worse at night and they find it difficult to fall or stay asleep, resulting in exhaustion and fatigue during the day. Sleep disturbances are often the reason that people suffering from restless leg syndrome seek a doctor's help. The problem also becomes obvious or worse during periods of rest or inactivity, for example while watching a movie, riding in a car, or sitting in an airplane. Walking, pacing, stretching or generally moving around provides some relief. Many people with restless leg syndrome also experience periodic limb movements in sleep (PLMS), which are involuntary jerking or bending leg movements that occur every 10 to 60 seconds, most often during periods of lighter sleep. DIAGNOSISDiagnosis of restless leg syndrome is usually based on the patient's description of symptoms, in addition to the person's medical and family history and a thorough physical examination. There is no single laboratory diagnostic test for restless leg syndrome, but blood tests or nerve or muscle studies may be performed to rule out other conditions such as anemia, diabetes or kidney failure, or to support a diagnosis of restless leg syndrome. Overnight sleep studies may be recommended to measure leg activity (periodic limb movements) during sleep. In most cases, the exact cause of restless leg syndrome is unknown (idiopathic), but it is frequently associated with an underlying condition such as iron deficiency, diabetes, anemia, or peripheral neuropathy, or a side effect of certain over-the-counter and prescription medications. Some women develop restless leg syndrome during the last several months of pregnancy, but the syndrome usually disappears after delivery. There may be a genetic component to some forms of restless leg syndrome. TREATMENTTreating an underlying condition, such as iron deficiency, diabetes or peripheral neuropathy, can often relieve many symptoms associated with restless leg syndrome. For people with mild-to-moderate cases of restless leg syndrome, eliminating or reducing the use of caffeine, tobacco, and alcohol can help alleviate some symptoms. Other ways to find some relief include moderate exercise, stretching, hot baths, massaging the legs, hot or cold packs, developing a consistent sleep routine, or relaxation techniques such as yoga or meditation. In some cases of restless leg syndrome, a variety of medications are used to control symptoms. The most commonly used drugs fall into four categories:
Unfortunately, no one medication is effective for everyone with restless leg syndrome. What may help one patient may actually worsen the symptoms for another. In addition, some medications taken on a regular basis may lose their effect, making it necessary to change medications periodically. Fentanyl Patch: Safety WarningThe FDA issued a public health advisory in mid-July about the safe use of transdermal fentanyl skin patches, in response to reports of deaths and narcotic overdoses among patients using the patches for pain control. The reports involved patients using the brand name fentanyl patches (Duragesic) as well as the generic product. At least some of the deaths may have been accidental. The government is trying to establish whether the deaths were related to inappropriate use of the patch or to product quality. The directions for using the fentanyl skin patch must be followed exactly in order to prevent death or other serious side effects from overdosing with fentanyl, a strong narcotic (opioid) medication. The FDA has also issued a patient information sheet that identifies safety precautions, including signs of overdose, proper patch application, use of other medications while using the patch, and proper storage and disposal. The safety warnings are available at http://www.fda.gov/cder/drug/InfoSheets/patient/FentanylPIS.pdf Discovery May Help Spinal Cord InjuriesThe same family of chemical signals that attracts developing sensory nerves up the spinal cord toward the brain serves to repel motor nerves, sending them in the opposite direction, down the cord and away from the brain, report researchers at the University of Chicago in the September 2005 issue of Nature Neuroscience. The finding may help physicians restore function to people with paralyzing spinal cord injuries. Growing nerve cells send out axons, long narrow processes that search out and connect with other nerve cells. Axons are tipped with growth cones, bearing specific receptors, which detect chemical signals and then grow toward or away from the source. In 2003, a team of scientists led by Jack Miller Center for Peripheral Neuropathy researcher Yimin Zou, Ph.D., assistant professor of neurobiology, pharmacology and physiology at the University of Chicago , reported that a gradient of biochemical signals known as the Wnt proteins acted as a guide for sensory nerves. These nerves have a receptor on the tips of their growth cones, known as Frizzled3, which responds to Wnts. In this paper, the researchers show that the nerves growing in the opposite direction are driven down the cord, away from the brain, under the guidance of a receptor, known as Ryk, with very different tastes. Ryk sees Wnts as repulsive signals. "This is remarkable example of the efficiency of nature," said Dr. Yimin Zou. "The nervous system is using a similar set of chemical signals to regulate axon traffic in both directions along the length of the spinal cord." It may also prove a boon to clinicians, offering clues about how to grow new connections among neurons to repair or replace damaged nerves. Unlike many other body components, damaged axons in the adult spinal cord cannot adequately repair themselves. An estimated 250,000 people in the United States suffer from permanent spinal cord injuries, with about 11,000 new cases each year. To read more about the study, click on Ryk-mediated Wnt Repulsion Regulates Posterior-directed Growth of Corticospinal Tract The full text of this article can be found at: http://www.uchospitals.edu/news/2005/20050815-wntproteins.html Pioneer Press Article - April 21, 2005The article, "Nerve Center Signals Hope: Jack Miller Center Takes Aim at Peripheral Neuropathy", appeared in 22 local editions of the Pioneer Press newspapers on April 21, 2005. The Pioneer Press serves the suburbs of Chicago with community newspapers in towns that include Glencoe, Evanston, Highland Park, Northbrook, Wilmette, Glenview, Lincolnshire, Deerfield, Kenilworth and Lake Forest. You may download the article here (254k pdf* file). Miller Center Researcher Wins NIH Award
Dr. Balabanov has a longstanding interest in demyelinating diseases that affect the peripheral and central nervous systems. The award will enable him to carry out a five-year research plan to learn how the process of demyelination works at the molecular level, with a goal of finding novel therapeutic approaches to peripheral nerve disorders. After receiving his M.D. in Bulgaria, Dr. Balabanov spent five years at Wayne State University working on neuroimmunology and autoimmune disorders. He received his neurology training at the University of Chicago, where he also served as Chief Resident. Following his graduation in 2004, he joined the Jack Miller Center as a research fellow in Dr. Brian Popko's laboratory. He is currently a clinical instructor in the Department of Neurology and is certified by the American Board of Neurology and Psychiatry. Congratulations!
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Jack Miller Center Research Fellow Dr. Roumen Balabanov is one of only 34 scientists nationwide to receive a Mentored Scientist Development Award from the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institutes of Health (NIH). This prestigious award is designed to recruit and prepare outstanding clinician research scientists for research and teaching careers related to neurological disorders. |
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