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Local Anesthetic ALGRX 3268 Demonstrates Statistically Significant Less Pain Compared With Placebo
This Phase 3 trial (004) was conducted at nine centers in the United States in patients 3 to 18 years of age. A total of 535 patients were administered a placebo (266 patients) or the local anesthetic, ALGRX 3268 (269 patients) one to three minutes before having their procedures which required either venipuncture or intravenous line placement. The primary endpoint was pain upon needle insertion utilizing the FACES pain scale.
The first Phase 3 trial (003) of ALGRX 3268 with an identical clinical trial protocol was conducted in 574 patients, and data from this pivotal trial were reported in October 2005. The primary endpoint of the pediatric trial was achieved showing that treatment with ALGRX 3268 demonstrated statistically significantly less pain (p=0.007) compared with the placebo group. ALGRX 3268 was well tolerated and demonstrated no significant safety issues.
"We are very pleased with the data announced today and believe that the results from these two Phase 3 clinical trials demonstrate that ALGRX 3268 could be beneficial to patients by reducing local pain with a much faster onset of action than the drugs that are currently on the market," stated Ronald M. Burch, M.D., Ph.D., chief executive officer of AlgoRx. "The data from these two trials will be included in a new drug application (NDA) for ALGRX 3268, which we expect to file with the FDA during 2006."
"With the positive Phase 3 dataset for ALGRX 3268 across more than 1,000 patients, we are focused on filing our NDA in an effort to achieve product approval in 2007," said John P. McLaughlin, chief executive officer of Corgentech. "We look forward to closing our proposed merger of Corgentech and AlgoRx in mid December. 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. We will file an amendment to our S-4 shortly updating it with our most recent financial information and other matters and expect the S-4 to then become effective."
About ALGRX 3268 and the Market Opportunity for a Fast-Acting Local Anesthetic
ALGRX 3268 represents a near-term product opportunity for which an NDA is expected to be filed in 2006. The product is aimed at reducing the pain associated with venipunctures and intravenous line placements. ALGRX 3268 is based on a needleless injection system called Powderject(R), which accelerates lidocaine particles, in powder form, into the epidermis in order to anesthetize nerves. The product, which may be especially useful in pediatric populations and emergency room settings, is easy to use and anesthetizes quickly -- generally in one minute -- offering an important advantage over currently available therapies.
Local anesthetics for venipunctures and intravenous line placements is an underserved market. Currently, in the largest children's hospitals and academic institutions in the United States, approximately 18 million venipunctures and intravenous line placements occur each year. Of these, topical local anesthetics are used in only approximately 2.1 million of these procedures given that the currently marketed products require from 10 to 60 minutes to offer benefit, compared with ALGRX 3268 which anesthetizes nerves within approximately one minute. With its fast onset-of-action, additional opportunities exist for ALGRX 3268 in the adult emergency room setting, hemodialysis and blood donation centers as well as physicians' offices and clinical laboratories.
Source: AlgoRx Pharmaceuticals, Inc. and Corgentech Inc.