Cumberland launches Phase II trials for AERD drug Boxaban

Cumberland Pharmaceuticals said on Wednesday that it is entering a Phase II development program for Boxaban (ifetroban), an oral capsule for the treatment of aspirin-exacerbated respiratory disease (AERD).

Cumberland received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) submission and the Boxaban phase II study.

AERD is a respiratory disease that includes chronic asthma and nasal polyposis, and is worsened by nonsteroidal anti-inflammatory medications. Approximately 1-in-20 adults with asthma suffer from AERD. The disease causes increases in platelet activity and inflammatory mediators within the respiratory system. Ifetroban may hinder these pathways and help relieve symptoms.

In 2011, Cumberland said it had procured the ifetroban program in partnership with Vanderbilt University and Cumberland Emerging Technologies (CET).

"Patients with AERD often have the most severe and difficult-to-treat form of asthma. The manufacture of the oral capsule formulation and initiation of the AERD clinical development program by Cumberland represents a significant milestone for our collaboration," Dr. John Oates, professor of medicine and pharmacology at Vanderbilt University, said. "Data from this important trial will help us to understand the potential for ifetroban in treating AERD while generating safety information that will allow us to consider ifetroban therapy for other patient populations."

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Organizations in this story

Cumberland Pharmaceuticals 2525 West End Ave Nashville, TN 37203

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903