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AlgoRx and Corgentech's powder-injected ALGRX 3236 anesthetic less painful, studies show
By Angela McDaniels
Seattle, Nov. 8 - AlgoRx Pharmaceuticals Inc. and Corgentech Inc. said data from phase-3 clinical trials shows children perceive their ALGRX 3236 local anesthetic to be less painful than traditional anesthetics.
ALGRX 3236 is administered into the skin by powder injection, rather than through venipunctures and intravenous line placements.
The primary endpoint of the phase-3 trial was achieved showing that treatment with ALGRX 3268 demonstrated statistically significantly less pain compared with the placebo group, the companies said. The patients measured their pain using the FACES pain scale.
Additionally, ALGRX 3268 was well tolerated and demonstrated no significant safety issues.
The trial was conducted at nine centers in the United States in 535 patients aged 3 to 18 years. This was the second of two phase-3 trials
The first phase-3 trial of ALGRX 3268 with an identical clinical trial protocol was conducted in 574 patients, and its data was reported in October. Results were the same, the company said.
"The data from these two trials will be included in a new drug application for ALGRX 3268, which we expect to file with the FDA during 2006," said Ronald M. Burch, chief executive officer of AlgoRx, in a company press release.
The companies aim to achieve product approval in 2007.
"We look forward to closing our proposed merger of Corgentech and AlgoRx in mid-December," said John P. McLaughlin, chief executive officer of Corgentech, in the press release.
"Three positive clinical data announcements have been made since the merger transaction was announced, and each of these affirms the benefits of this merger for our stockholders,"
AlgoRx is a pharmaceutical company based in Seacaucus, N.J., that develops products to address pain.
Corgentech is a biopharmaceutical company based in South San Francisco, Calif., that develops
therapeutics for significant unmet medical needs.
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