If you have ever had to undergo a surgery there is a good chance you woke up afterwards groggy and in pain. In a world where doctors and people are trying to veer away from opioids that pain issue is one that patients have to deal with. There now appears to be new help on the way. The FDA has now approved an expanded labeling for Caldolor to be used intravenously for prior to surgery.
Cumberland Pharmaceuticals Inc. (CPIX) announced on November 29, 2021 that the FDA has approved Caldolor in an expanded labeling of its intravenously delivered formulation of ibuprofen after the administration was shown to significantly reduce pain intensity. As this is ibuprofen it is a non-narcotic pain reliever. Doctors may now administer Caldolor just before surgery so that patients will wake up after their procedures in significantly less pain.
While this is an expanded use labeling by the FDA rather than a new drug approval, it had already shown to manage mild to moderate pain and also moderate to severe pain as an adjunct to opioid analgesics. It had also been shown to help in reducing fever as ibuprofen.
Please be advised that Caldolor may not be appropriate for every single patient about to enter surgery (see below).
According to Cumberland Pharma’s press release, this newly FDA-approved label includes information regarding Caldolor’s indications and usage, appropriate patient populations, clinical study results, potential side effects, and patient safety details. The new label also includes instructions for its use in pregnant women, children, and other populations.
Caldolor was already the first FDA-approved intravenous therapy for fever. It is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, as well as patients with asthma or other allergic-type reactions after taking aspirin or other NSAIDs. Caldolor is also contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft surgery.
A study of orthopedic surgical pain confirmed the significant pain reduction when Caldolor was administered every six hours after having been administered prior to surgery and with supplemental morphine available on an as needed basis.
Cumberland Pharmaceuticals also showed that 185 patients were randomized and treated with either Caldolor 800 mg or placebo ahead of surgery and every six hours thereafter, and morphine was provided on an as needed basis. Caldolor’s efficacy was demonstrated a statistically significant greater reduction in pain intensity over 24 hours after surgery versus the patients who were administered the placebo.
The approval does come with a boxed warning and the company said that it should be used in caution in patients with a history of ulcer disease, GI bleeding, those with fluid retention or heart failure, the elderly, and patients with renal impairment, heart failure, and liver impairment. Blood pressure should be monitored during product treatment. Caution should also be used for patients taking diuretics or ACE inhibitors. Caldolor’s full safety and adverse reactions data have already been made available by Cumberland, and the company has also already released its clinical data.
A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals, said:
“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. We 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. We feel confident that this important development provides additional insights into how intravenous ibuprofen can help healthcare professionals and patients as elective surgeries resume.”