A fixed dose combination of ibuprofen and famotidine

Abstract

The NSAID class of medications is frequently used for mild to moderate pain. While overall safe, NSAIDs have several important adverse effects including esophageal, gastric and duodenal ulceration which limit their use. This has led to the development of NSAIDs with either less gastrointestinal side effects or concurrent use of medications to prevent NSAID gastrointestinal side effects. While several classes of medications exist for the prevention of gastrointestinal side effects, few combination treatments are available in a single pill. Towards this end, a combination pill of ibuprofen and famotidine (HZT-501, Horizon Therapeutics, Skokie, IL. USA) has been developed.

The use of H2 antagonists in treating and preventing NSAID-induced mucosal damage

“…This holds true for patients started on two medications, for patients having a second medication added to their one-drug regimen, and when patients already on a two-drug regimen are switched to a fixed-dose combination. Compliance improves from 37% to 50 to 67%, from 54% to 77%, and from 71% to 84%, respectively, for each scenario [31]. …”

“…Thus, many patients who are already taking PPIs for GERD will be unable to switch to H2RA/NSAID or misoprostol/NSAID combination therapy to treat both GERD and pain requiring NSAIDs [31]. …”

“…Concern for CV toxicity has led to decreased usage of these agents. After market withdrawals, celecoxib is currently the only coxib available in the United States [31]. Concern was raised recently about the potential CV risk of both selective and nonselective NSAIDs since these drugs appear to increase the risk of subsequent cardiac events following a myocardial infarction [46].…”

Prevention of NSAID-Associated Gastric Ulcers: Comparison of PN 400 (Enteric-Coated Naproxen with Esomeprazole) versus Enteric-Coated Naproxen Alone

“…The trial by Goldstein et al provides a promising solution by combining naproxen and esomeprazole into a single formulation (PN 400), since combination medications have been shown to improve compliance. 15 These single formulations are limited, however, because PPI therapy demands a different dosing schedule than NSAIDs. 16 Physicians should consider the currently available single formulations, such as misoprostol plus diclofenac (Arthrotec; Pfizer Inc, New York, NY).…”

“…Another viable option is lansoprazole plus naproxen (Prevacid NapraPAC; Takeda Pharmaceuticals, Chuoku, Osaka, Japan), which provides the medications in the same blister pack, but still requires patients to take 2 different pills. 15 Lastly, regardless of co-therapy guidelines, gastrointestinal side effects of NSAIDs have proved problematic. The trial by Goldstein et al demonstrated that the addition of esomeprazole with EC naproxen into PN 400 resulted in fewer adverse events and fewer medication discontinuations when compared with EC naproxen alone.…”