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Data Presented on September 6th in London
MENLO PARK, CA (September 06, 2008) – ROXRO PHARMA, Inc. today presented additional results of its product candidate ROX-828 which is in development for the treatment of migraine pain. These data are a follow on to its previously announced successful Phase 2 proof of concept study.
The data were presented in a poster at The European Headache and Migraine Trust International Congress in London. ROXRO presented additional information on ROX-828 indicating that more patients treated with ROX-828 achieved pain relief and pain free status than those treated with placebo. ROXRO also presented data indicating that associated migraine symptoms, such as nausea, vomiting and sensitivity to noise were improved with ROX-828 treatment. In addition, more patients who received ROX-828 reported “much better” and “very much better” efficacy 2 hours after dosing, than did patients who received placebo (p=0.008).
"We are pleased to present our encouraging data at this important migraine meeting," said ROXRO chief executive officer Roberto Rosenkranz. “We believe that a well tolerated intranasal formulation of ketorolac would provide an important new alternative to migraine patients, particular those who suffer from nausea during their migraine attacks.”
ROX-828 is an intranasal formulation of ketorolac, a non-steroidal anti-inflammatory medicine most often administered as an intramuscular injection or intravenously for the short-term treatment of moderate-to-severe pain.
ROXRO is also developing a different formulation of ketorolac, ROX-888 for acute moderate-to-severe pain. ROXRO anticipates filing a New Drug Application this year with the U.S. Food and Drug Administration for approval to market ROX-888.
ROXRO PHARMA, Inc., of Menlo Park, Calif., is a privately owned specialty pharmaceutical company focused on the treatment of pain. Founded in 1999, ROXRO in-licenses promising drug candidates for rapid development in acute medical conditions. The company's highly experienced management team engages a global network of external experts to conduct pre-clinical and clinical studies and to manufacture drug products. ROXRO’s lead compound, ROX-888, has completed Phase 3 trials for the treatment of acute moderate-to-severe pain. The company's earlier pipeline includes a Phase 2 compound for migraine.