Recently, Cumberland Pharmaceuticals Inc (CPIX) announced that Caldolor (Ibuprofen), its candidate for treating pain and fever, reduced fever in burn patients over the first 24 hours of treatment in a multi-center, randomized, double-blind study. The drug, an intravenous therapy, was well tolerated and is fit enough to be administered to hospitalized burn patients for five consecutive days without any safety concerns.
The 61 adult burn patients evaluated in the study suffered from second or third degree burns covering more than 10% of the body surface area. The study also comprised of a few subjects who anticipated a hospital stay in excess of 3 days and temperatures greater than or equal to 100.40 F. The patients were administered with 800 milligrams of Caldolor injection every six hours for five consecutive days. The efficacy and safety data of the injection were compared with those obtained for a placebo. The adverse reactions arising from the Caldolor administration were similar to those reported for placebo.
As a reminder, the U.S. Food and Drug Administration (FDA) approved Caldolor, the intravenous formulation of ibuprofen, in Jun 2009. The product, launched in Sep, is the first injectable product available in the U.S. for treating pain and fever. The injection is used primarily for treating hospitalized patients who cannot receive oral drugs for pain relief and fever reduction.
As per data from the American Burn Association, 1.1 million burn injuries in the U.S. require medical attention each year. Furthermore, burn-related infections cause up to 10,000 deaths in the U.S. every year. Caldolor, therefore, can address a substantial market.
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