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ROXRO Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain
Date:2/6/2009

MENLO PARK, Calif., Feb. 6 /PRNewswire/ -- ROXRO announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead investigational prescription drug candidate, ROX-888, for the management of acute moderate to severe pain. ROX-888 is an intranasal formulation of ketorolac, a non-steroidal anti-inflammatory drug (NSAID), designed to provide ambulatory patients with a convenient, potent, and fast-acting option for acute pain relief, without the risk of addiction or the other negative effects of narcotics. The NDA package for ROX-888 includes data from more than 1,000 subjects and 14 clinical trials. If approved, ROX-888 is expected to be the first non-narcotic intranasal analgesic indicated for the management of acute moderate to severe pain.

(Photo: http://www.newscom.com/cgi-bin/prnh/20090206/AQF506)

"This milestone for ROX-888 is a significant business accomplishment for ROXRO. Our virtual operating structure has enabled us to develop an extensive NDA package for our lead product candidate in an extremely capital-efficient manner," said Roberto Rosenkranz, Chief Executive Officer of ROXRO. "We believe that ROX-888 has the potential to fill important needs in the large and growing market for acute moderate to severe pain treatments. Currently approved forms of ketorolac are already well accepted by the physician community for in-hospital use, and we believe physicians will quickly adopt this investigational intranasal form of ketorolac as a new therapeutic option to replace or minimize oral opioid use for take-home prescriptions. As we plan a potential product launch at the end of 2009, pending FDA approval, we are now seeking a commercialization partner to help us realize the full benefit of this drug."

ROX-888 has been tested in four contro
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SOURCE ROXRO PHARMA, Inc.
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