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LGD 4033 was developed with the goal of preventing muscle loss in the elderly and in those who suffer from muscle dystrophy," says Mark Shriver, MD, chairman and professor of cardiology and biostatistics at the University of Kansas Medical Center in Kansas City and medical director of The Center for Muscular Dystrophy and Muscular Dystrophy Program, a joint FDA/USPTO (United States Public Health Service) program that coordinates clinical trials evaluating new drug treatments related to muscle-related disease and has established a program for studying muscle-related diseases. MD Shriver says that GD4033, which is currently in preclinical development for Parkinson's disease and Alzheimer's disease, can be combined with other drugs to help patients manage motor decline, and that in some cases patients actually gain as much as 20% in muscle size. "The bottom line is that people can do this without being sedentary and without feeling like they are doing it poorly," says MD Shriver, who heads the GD4033 Clinical Program, which supports the scientific process. "They can get better at it." Although the FDA has not approved the compound to treat MS, a similar compound, GD5033, has been approved for the treatment of multiple sclerosis and has shown promising results. The drugs have the potential to be used together, MD Shriver says, because they target different neurotransmitters. "We've already shown that if you combine them, we might be able to achieve this," he says. Also, MD Shriver believes that the drugs combined could treat a variety of symptoms associated with muscle dystrophy and skeletal muscle diseases in people living with those diseases. A number of drugs, including Nardil (dexamethasone) and Nubivac (valproate), have been used with success to increase muscle mass and strength in patients without a history of those diseases. "We're now moving toward development of this compound as an MS drug," says MD Shriver. There are currently two studies underway to assess the safety and efficacy of GD4033 as an MS drug, one in a small pilot clinical trial and the other in a larger clinical trial of 50 patients. If both data are as promising as MD Shriver predicts, then the FDA could see its approval next year. Similar articles:
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