IOMED has reported that its confirmatory Phase III trial of G-II(formerly ProDex), a formulation of dexamethasone based on its Phoresor iontophoretic drug delivery technology, has failed to back up the results of its earlier trials in epicondylitis (golfer's or tennis elbow). The company will not now be able to file for approval of the drug in the middle of 2001, as it had originally planned.
IOMED's chief executive, James Weersing, commen ted that the company will undertake an assessment of all its data on the drug before deciding on an appropriate course of action concerning the program, although he expressed confidence on the merits of the local anti-inflammatory program. The firm has a follow-up formulation of dexamethasone, known as IontoDex, in clinical trials. This product is based on the same iontophoretic technology as G-II (which involves the transport of water-soluble ionic drugs into and through skin and other body tissues using a mild electrical current) but is designed for self-administration by the patient, rather than by a health care provider.
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