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A new medication may soon be available for patients who suffer from advanced gastroparesis, or delayed emptying of the stomach contents. Tranzyme Pharma is presenting data on its experimental drug ulimorelin later this month at the 2010 Joint International Meeting in Neurogastroenterology and Motility in Boston, Mass.
Two more lawsuits have been filed in federal court in New Orleans against the manufacturers of an acid reflux medication that allegedly causes a debilitating involuntary movement disorder known as tardive dyskinesia. Ellen Austin filed a suit against Actavis, Actavis Elizabeth and Watson Pharmaceuticals. Leslie Keeper filed suit against Qualitest Pharmaceuticals. Both lawsuits claim the drug Reglan, also known as the generic metoclopramide, caused them to develop the movement disorder.
Tranzyme Pharama says its new treatment for diabetic gastroparesis, a disabling disorder in which the stomach takes too long to empty its contents, has shown positive results in phase II clinical trials among diabetic patients with the digestive disorder. The pharmaceutical company was granted “fast-track status” by the Food and Drug Administration (FDA) for TZP-102, a designation that is typically reserved for drugs that treat serious and unmet medical needs. The designation is designed to speed up the review and approval process.
Makers of generic drugs who do not adequately label their products to warn consumers of possible risks are not exempt from liability, according to a ruling by the U.S. Court of Appeals for the Eighth Circuit. The court ruled on a product liability lawsuit brought by Gladys Mensing, who was prescribed metoclopramide to treat diabetic gastroparesis, a debilitating condition in which the stomach empties too slowly. Following use of the medication, Mensing developed a serious movement disorder known as Tardive Dyskinesia. Research has shown that the condition can be caused by long-term use of metoclopramide. Mensing sued several makers of generic metoclopramide, known by the brand name Reglan, for not adequately warning consumers of the risk of developing the movement disorder.
Salix Pharmaceuticals’ new gastrointestinal disorder treatment Metozolv (metoclopramide) OTC (orally disintegrating tablet ) utilizes Zydis, a fast-dissolve technology made by Catalent Pharam Solutions. Zydis is a unique, freeze-dried oral solid dosage form that can be swallowed without water because it dissolves instantly on the tongue in less than three seconds, according to Catalent. This delivery method translates to dosing convenience and ease of administration that makes taking medication easier for patients.
An abnormal wiring in the brain may counteract genetic mutations for dystonia, and may lead to new treatment and prevention options for patients with movement disorders, according to the Journal of Neuroscience.
Salix Pharmaceuticals, Ltd., makers of medicines for various gastrointestinal ailments, has received marketing approval from the Food and Drug Administration (FDA) for Metozolv ODT for the treatment of both diabetic gastroparesis and symptomatic documented GERD. Metozolv ODT is an orally disintegrating metoclopramide tablet. Metoclopramide was previously only available in the United States in a pill form under the brand name Reglan.
Tranzyme Pharma’s new drug to treat diabetic gastroparesis has been granted a fast-track designation by the Food and Drug Administration (FDA), allowing it faster access to FDA personnel as it moves through the approval process. The new medication, called TZP-102, has just moved into phase II trials in humans. If the trials run smoothly, the drug should enter phase III trials next year with approval by 2013 at the earliest. The fast-track designation is reserved for drugs that treat serious and unmet medical needs.
People who suffer from heartburn, GERD or diabetic gastroparesis are often prescribed metoclopramide, known in the U.S. by the brand name Reglan, to treat their condition. Recent warnings issued by the Food and Drug Administration (FDA), however, may make those individuals consider natural alternatives before turning to pharmaceuticals.
Prokinetic drugs, such as Reglan (metoclopramide) are those that increase the movement of ingested material through the gastrointestingal tract. They are usually prescribed to treat diabetic gastroparesis, heartburn and nausea and vomiting in chemotherapy patients. Unfortunately, some prokinetic drugs may produce a number of serious side effects.
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