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January 5, 2009
Anesiva reported positive results from a phase III trial of Adlea for the reduction of post-surgical pain following total knee replacement surgery. This multi-center, randomized, double-blind, placebo-controlled phase II study, dubbed ACTIVE-2, enrolled 217 subjects undergoing total knee replacement. The subjects were randomized to receive either a single 60 mL dose of Adlea (0.25 mg/mL drug concentration) or placebo instilled into the surgical site immediately prior to wound closure. The primary endpoint was a time-weighted pain score (using a standard 0 - 10 numerical rating scale of pain intensity) from four to 48 hours following knee replacement surgery. The study achieved its primary efficacy endpoint of reducing post-surgical pain versus placebo (p≡0.03). Adlea also demonstrated a highly significant reduction in opioid medication consumption compared to placebo (p≡0.005), a key secondary endpoint. Phase III trials are currently underway.
September 1, 2008
Bristol-Myers Squibb and Pfizer reported negative preliminary results from a phase III trial of apixaban for the prevention of venous thromboembolism (VTE). This study, dubbed ADVANCE-1, enrolled 3,000 subjects undergoing knee replacement surgery. The subjects received apixaban, 2.5 mg given twice daily, or enoxaparin, 30 mg given twice daily. The primary efficacy outcome, a composite of symptomatic or asymptomatic deep vein thrombosis, pulmonary embolism, and death by any cause, was not reached. The rate of the primary efficacy endpoint on apixaban was similar to that observed with enoxaparin (9.0% versus 8.9%, p=.064), but did not meet the statistical criteria for non-inferiority compared to enoxaparin. There were no unexpected adverse events. The major bleeding event rate for apixaban was lower, but was not significantly lower, than enoxaparin (0.7% versus 1.4%, p=.053). In addition, the composite rate of clinically relevant non-major bleeding and major bleeding was significantly less in subjects who received apixaban than those who received enoxaparin (2.9% versus 4.3%, p =.034). Several additional phase III trials of apixaban are currently underway.
July 16, 2007
Portola issued positive results from a phase II trial of PRT054021 for the prevention of venous thromboembolic events (VTE). This randomized, active-control study enrolled 215 subjects undergoing total knee replacement surgery. Subjects received 15 or 40 mg of PRT054021 orally twice a day or 30 mg of Lovenox (enoxaparin) subcutaneously twice a day, for 10-14 days. The primary efficacy endpoint was incidence of VTE through day 10-14 measured by venography. The primary safety endpoint was the incidence of major and clinically significant non-major bleeds through the day after venography. The incidence of VTE was 20% (95% Confidence Interval 12%-32%), 15% (8%-27%) and 10% (3%-23%) in the low dose PRT054021 group, the high dose group of PRT054021, and in the enoxaparin group, respectively. No major bleeds were seen in the PRT054021 and one major bleed was seen in the enoxaparin group. No significant non-major bleeds were identified in the PRT054021 low dose group and two were identified in the PRT054021 high dose group. Two significant non-major bleeds in the enoxaparin group were also observed. Based on the results, Portola plans to initiate phase III trials in the first half of 2008.
November 18, 2002
AstraZeneca reported positive results from a phase III trial of Exanta (ximelagatran) versus enoxaparin, a low-molecular-weight heparin for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Data showed Exanta significantly reduced the risk of proximal DVT and PE by 6.3% compared to 2.3% with enoxaparin. The randomized, double blind, double-dummy study included nearly 2,800 subjects worldwide, undergoing either total knee replacement or total hip replacement surgery. In the study, 1,377 subjects received Exanta and 1,387 received enoxaparin. There were no fatal or critical-site bleeding events in either group. However, excessive bleeding at the operative site, as judged by the investigator was more common in the group receiving Exanta (3 % vs. 1.2 %).