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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

lled efficacy studies, and met the primary endpoints in each trial. Additionally, ROX-888 has demonstrated a good safety profile, as would be expected with short-term use of an NSAID. Mild, transient nasal irritation was the most common side-effect of ROX-888 usage. As with other NSAIDs, ROX-888 should not be used in patients with renal insufficiency, active peptic ulcers, or a history of GI bleeding.

"ROX-888 could fulfill a compelling medical need for both clinicians and patients -- an analgesic that provides potent, rapid-onset pain control while minimizing the potential for abuse and the negative side-effects perceived to be associated with narcotic pain relievers," said Dr. Neil Singla, Chief Executive Officer of Lotus Clinical Development, Inc. and lead investigator for ROXRO's second Phase 3 study. "If approved, the nasal spray product, formulated for convenient use, will provide patients pain relief at home or in an out-patient or ambulatory setting, without the need for injections or intravenous administration."

About ROX-888

ROX-888 is a novel, investigational intranasal formulation of the potent non-steroidal anti-inflammatory drug (NSAID) ketorolac. Currently, ketorolac is most often administered in the hospital setting as an intramuscular injection or intravenously for the short-term treatment of moderate to severe pain. The analgesic efficacy of ketorolac is primarily associated with the inhibition of prostaglandin synthesis via non-selective inhibition of COX-1/COX-2 enzymes. Based on clinical studies conducted to date, ROX-888 is expected to allow patients to receive the same benefits of hospital-strength ketorolac in a convenient form that can be used at home. Formulated as an easy-to-use spray, ROX-888 is rapidly absorbed through the nasal mucosa, achieving peak blood levels as fast as an intramuscular injection. The pharmacokinetic properties of ROX-888 have been demonstrated i
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SOURCE ROXRO PHARMA, Inc.
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