First IV formulation for acetaminophen approved

FDA has approved acetaminophen injection (Ofirmev, Cadence Pharmaceuticals), the first intravenous (IV) formulation of acetaminophen for the management of mild-to-moderate pain, moderate-to-severe pain with adjunctive opioid analgesics, and the reduction of fever.

Craig I. Coleman, PharmD, from the School of Pharmacy at University of Connecticut, Storrs, and editorial advisor to Formulary, Drug Topics’ sister publication, stated, “The approval of intravenous acetaminophen is a welcome addition to the U.S. armamentarium of drugs to manage pain and fever.

“It provides an important alternative to current narcotic and nonsteroidal anti-inflammatory agents, particularly in patients not able to tolerate oral medications. Of course, the pricing of the intravenous formulation will be a major determinant of its extent of use.”

Acute pain, particularly postoperative pain, often requires a multi-modal approach, in which 2 or more analgesics are used with the goal of providing better analgesic efficacy. U.S. physicians already prescribe acetaminophen frequently in combination with opioids for oral management of pain when it is the most widely used non-opioid in fixed combination therapies. In clinical studies, Ofirmev improved pain relief, reduced opioid consumption, and improved patient satisfaction when used as part of a multi-modal regimen.

FDA approval of Ofirmev was based on data from clinical trials in which a total of 1,020 adult and 355 pediatric patients received IV acetaminophen. These trials included 2 studies evaluating the safety and effectiveness of Ofirmev in the treatment of pain, and one study evaluating Ofirmev in the treatment of fever. In a study of 101 orthopedic patients undergoing hip- or knee-replacement surgery, Ofirmev 1,000 mg every 6 hours was statistically superior to placebo for the reduction of pain intensity over 24 hours (P<.01), with significantly reduced morphine consumption (33% over 24 hours, P<.01). In a second study of 244 patients undergoing abdominal laparoscopic surgery, Ofirmev 1,000 mg every 6 hours, or 650 mg every 4 hours, demonstrated a significant reduction in pain intensity over 24 hours compared to placebo (P<.02).

In a study of adult volunteers with induced fever, a single dose of Ofirmev 1,000 mg demonstrated a statistically significant reduction in temperature through 6 hours in comparison to placebo (P