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Hemostatic Agent Raplixa (Fibrin Sealant) Shows Promise in Phase III Trial

Treatment significantly reduces time to hemostasis versus gelatin sponge

Positive results have been reported from a pivotal phase III trial of the investigational hemostatic agent Raplixa (fibrin sealant, The Medicines Company), formerly known as Fibrocaps, at the 100th Clinical Congress of the American College of Surgeons, held October 26–30 in San Francisco, California.

The FINISH-3 trial, which involved a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four surgical indications: spinal surgery, hepatic resection, vascular surgery, and soft-tissue dissection.

Raplixa, currently under FDA review, is a ready-to-use, dry-powder topical formulation of two essential blood-clotting proteins, fibrinogen and thrombin, that is being developed to aid in hemostasis during surgery. The product is not currently approved for commercial use in any market.

FINISH-3 was an international, randomized, single-blind, controlled trial that compared the efficacy and safety of Raplixa and a gelatin sponge (n = 480) with that of a gelatin sponge alone (n = 239) for use as a hemostat for surgical bleeding in four indications: spinal (n = 183), vascular (n = 175), hepatic (n = 180), or soft-tissue (n = 181) procedures. Adults with mild-to-moderate surgical bleeding were treated at a single bleeding site (day 1). The time to hemostasis (TTH) over 5 minutes was compared within each indication. Safety follow-up continued to day 29. Raplixa was applied with a spray device in 53% of all procedures (94% of hepatic and soft- tissue procedures).

Raplixa and a gelatin sponge significantly reduced TTH compared with a gelatin sponge alone; estimated hazard ratios were 3.3, 2.1, 2.3, and 3.4 for the four surgical indications, respectively (each P < 0.001; the trial’s primary endpoint). Moreover, Raplixa significantly reduced median TTH for each indication (P < 0.0001), and was superior for the secondary efficacy endpoints of restricted mean TTH (P < 0.0001) and the probability of hemostasis at 3 (P < 0.0001) and 5 (P ≤ 0.002) minutes.

Non-neutralizing antithrombin antibodies developed in 2% of the Raplixa-treated group and in 3% of the gelatin sponge-treated group.

Source: The Medicines Company; October 28, 2014.

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