Cumberland Pharmaceuticals Stock Rockets After FDA Approves Labeling

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Cumberland Pharmaceuticals Stock Rockets After FDA Approves Labeling
Credit: © Reuters.

By Sam Boughedda — Cumberland Pharmaceuticals Inc (NASDAQ: CPIX ) Shares have more than doubled Tuesday after the U.S. Food and Drug Administration approved expanded labeling for Caldolor, an intravenously delivered formulation of ibuprofen.

While the news may not sound all that exciting, investors have jumped at the chance to purchase Cumberland shares, with the stock hitting a high of $4.76 shortly after the open. They currently trade around the $4.40 mark.

Cumberland said the non-narcotic pain reliever can now be administered before surgery to enable patients to wake up from their procedure in "significantly less pain."

The new labeling, which the FDA approved, includes numerous information, including the product's expanded usage, clinical study results, potential side effects, patient safety details, and more.

"Before the pandemic began, healthcare systems across the country were in the midst of a public health mission to control surgical pain while decreasing opioid consumption," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. 

The company said a study of orthopedic surgical pain in 185 patients confirmed the significant pain reduction when the product was administered every six hours, a benefit not overlooked by surgeons, with Dr. Stephen Southworth, an orthopedic surgeon at the Orthopedic Institute of North Mississippi saying that "when administered immediately prior to surgery, patients given Caldolor experience less postoperative pain and a decrease in their opioid use."

Cumberland's CEO concluded that they "are proud to see the continued support for Caldolor's use in surgical care, with the product's approved labeling now including the expanded use of the product prior to surgery," added Kazimi. 

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