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intravenously, MediciNova says, ER doctors know exactly how much of the drug has been administered. The company is nearing completion of a mid-stage trial of 176 patients in more than 20 U.S. hospitals (including UC San Diego and UCLA).
The firm says it plans to release results of its mid-stage trial by June 30, and Iwaki voices confidence about moving to late-stage trials sometime next year.
[Corrects to show the drug was in clinical trials, not approved, as a uterine muscle relaxant] In Japan, the drug was in clinical trials as a uterine muscle relaxant for women in pre-term labor. Medicinova initially considered seeking FDA approval for treating pre-term labor in the United States. But Iwaki says the company decided instead to seek regulatory approval for treating acute asthma episodes after the FDA said it would require additional testing of pregnant women that could add up to four years to the drug development timeline. “More than the [additional] costs, we were concerned about the timelines,” Iwaki says.
In researching the market potential for treating asthma, however, MediciNova found there are 20 million people in the United States with asthma, according to Mark Johnson, MediciNova’s director of investor relations and corporate development. Acute asthma episodes are unpredictable and result in some 1.9 million ER visits throughout the U.S. every year. In roughly one out of four of those visits, Johnson says, the patient is hospitalized at an average cost of nearly $6,500.
MediciNova says bedoradrine, if approved, could potentially reduce hospital admissions of asthma patients by … Next Page »
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