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.
Gastroparesis, or delayed emptying of the stomach contents, affects nearly 1.5 million people and can cause pain, bloating, vomiting and malnutrition. GERD, or gastroesophageal reflux disease, affects approximately one-third of the U.S. population. Metozolv ODT is designed for sufferers of both conditions who have difficulty swallowing, need treatment but do not have water available, or need a portable way to take medication. Metozolv ODT rapidly melts on the tongue and gives patients an alternative to the pill form of metoclopramide.
Metozolv ODT will carry the same black box warning as the brand name metoclopramide, Reglan, which warns users that long-term therapy (12 weeks or longer) increases one’s risk of a serious involuntary movement disorder known as Tardive Dyskinesia. The condition is disabling and does not usually go away once treatment with metoclopramide has stopped.
Metozolov ODT packaging will also warns users that the drug should be used with caution in patients showing acute dystonic reactions, drug-induced Parkinsonism, or other extrapyramidal symptoms, and neuroleptic malignant syndrome with a prior history of depression.
Last week, in anticipation of the FDA’s approval, Salix announced that it will increase its sales force by 60 percent to help market Metozolov ODT. The drug has patent protection until 2017, and additional patent protection pending that, if issued, could provide patent protection until 2025.