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MEDI-PHYSICS' IN VIVO IMAGING AGENT SPECTamine

Executive Summary

MEDI-PHYSICS' IN VIVO IMAGING AGENT SPECTamine is initially approved for "evaluation of nonlucunar stroke especially when used within 96 hours of the first onset of neurological deficit." The approved indication for the iofetamine HC1 I 123 product also notes that "the rates of agreement between abnormal images and the neurological examination suggestive of ischemic cerebrovascular insufficiency, appear to increase with the severity of symptoms." The indication, approved by FDA on Dec. 24 (NDA 14 932), also points out that the product's "usefulness for the measurement of cerebral blood flow has not been established." The product took 35 months to clear FDA; regulatory reviews of three years or more are not typical for radiopharmaceuticals. The product will be introduced on Feb. 8. While FDA gave the product a "C" (minor therapeutic gain) rating for the initial approval, Medi-Physics' parent Roche has been touting the product's eventual potential based on its ability to cross the blood/brain barrier. Medi-Physics has studies underway for additional indications including the evaluation of intervention during acute stroke and the evaluation of Alzheimer's disease. The clinical pharmacology section of labeling points out the drug's ability to penetrate the brain. "Animal studies," labeling states, "have shown that iofetamine HC1 I 123 is removed from the circulation via first pass metabolism primarily by the brain and liver; the extraction fraction in the brain is 74-92%." The company also reports that animal studies "suggest that retention in the brain is due to binding by relatively non-specific, high-capacity binding sites." The labeling also notes that in humans at 1,5 and 22 hours, the percentages of the drug remaining in the brain were 5.7%, 12.5%, and 16.8%. None of the human studies "demonstrated any constant plateaus in concentration within any organ."
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