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FDA Law Weekly

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Asthma



MAP Pharmaceuticals Reports Positive Phase 2 Results for its Pediatric Asthma Drug Candidate



March 15th, 2007

MAP Pharmaceuticals, Inc. announced that its Unit Dose Budesonide (UDB) drug candidate met its primary efficacy endpoints in a Phase 2 clinical trial. UDB is a proprietary nebulized formulation of budesonide for treatment of pediatric asthma.

The multicenter, randomized, double-blind, placebo-controlled U.S. based study aimed to assess the efficacy of UDB versus placebo at two doses in patients as young as 12-months old. The study met its primary efficacy endpoints. The high dose evaluated in the study was equivalent to the lowest dose available of the currently marketed nebulized budesonide product.

The primary endpoints for the study were asthma...


Source: FDA Law Weekly (2007-03-15)

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