Shares of drug maker, Cumberland Pharmaceuticals, Inc. (Nasdaq: CPIX) surged as much as 32 percent from Thursday’s closing price in morning trading on Friday after the company announced that it received approval from the U.S. Food and Drug Administration for a new formulation of its liver drug.
The drug, Acetadote, which has been available in the United States since Cumberland’s 2004 introduction of the product, is currently used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products.
Cumberland is immediately commencing U.S. launch activities for the next generation of Acetadote, and will discontinue to manufacture the previously approved formulation.
The approval could not have come at a more opportune time. Cumberland’s announcement dropped on the same day the FDA said it will cap the amount of acetaminophen in various drugs at 325 milligrams per capsule because of the potential for toxic overdoses when taken in combinations.
“We look forward to introducing this next generation product to the hospital community and the growing number of patients who will benefit from it,” Cumberland Pharmaceuticals’ CEO A.J. Kazimi said in a statement.
In March the company had filed a supplementary new drug application for an indication of Acetadote to treat liver failure caused by factors such as hepatitis B and autoimmune hepatitis.
The FDA rejected the application for the new indication, stating that it did not offer sufficient evidence of efficacy in increasing survival in all patients with acute liver failure.
Shares of CPIX are up about 3 percent over the past three months.