ROXRO ANNOUNCES FDA APPROVAL OF SPRIX™(Ketorolac Tromethamine)
MENLO PARK, CA (May 17, 2010) –
ROXRO PHARMA, Inc. made an announcement on May 17, 2010 on their website ww.roxropharma.com that the United States , Food and Drug Administration (FDA) has approved their Nasal Spray formulation containing ketorolac tromethamine, with the brand name SPRIX™ for a short‐term use (up to 5 days) for managing acute or moderate to moderately severe pain which otherwise requires an analgesia at the an opioid level. SPRIX™ is a non‐steroidal anti‐inflammatory prescription drug (NSAID) which is an intranasal formulation of the analgesic ketorolac tromethamine, it is designed to induce an analgesia and pain relief in case of ambulatory patients with a convenience, it is a potent, and fast‐acting option for acute moderate to moderately severe pain. Ketorolac tromethamine is a non‐narcotic injectable analgesic it is often used in case of moderately severe pain in hospitals. After an approval for SPRIX from US FDA, outpatients with acute pain can be provided with a nonnarcotic and easy‐to‐administer alternative to commonly prescribed opioids.
There are some negative side effects related with narcotic pain relievers while providing potent control of moderate to moderately severe pain at the opioid level. Such a convenient nasal spray formulation will also provide pain relief outside of the hospital setting.
SPRIX is said to be a novel drug delivery system intranasal formulation of the potent non‐steroidal anti‐inflammatory drug (NSAID) ketorolac. At present, ketorolac is frequently administered in the hospital setting as an injection in the short term treatment for moderately severe pain. Ketorolac Tromethamine is formulated as an easy to use spray, using novel drug delivery system. SPRIX is said to be rapidly absorbed through the nasal mucosa, achieves peak blood levels as fast as an ketorolac intramuscular injection of. SPRIX has been studied in moderate to moderately severe pain, both alone and in combination with morphine.
The New Drug Application ( NDA ) package of SPRIX was included a data obtained from more than 1,000 subjects and 14 clinical trials. SPRIX has been tested in four controlled efficacy studies, and met the primary efficacy endpoints in each clinical trial. Phase 3 studies of adults who underwent elective abdominal or orthopedic surgery (n=300 and N=321) indicated that SPRIX provided a statistically significant greater reduction in the summed pain intensity difference, a commonly accepted measure of pain, over 48 hours as compared to those using placebo. SPRIX has also demonstrated a 26‐36 percent reduction in morphine use by patients over a 48 hour period as compared with placebo.
Important Safety Information About SPRIX (Ketorolac Tromethamine)
LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, & RENAL RISK
• Limitations of Use – The total duration of use of SPRIX and other ketorolac formulations should not
exceed 5 days.
• Gastrointestinal (GI) Risk – Ketorolac can cause peptic ulcers, GI bleeding, and/or perforation of the
stomach or intestines, which can be fatal. SPRIX is CONTRAINDICATED in patients with peptic ulcer
disease or history of GI bleeding.
• Bleeding Risk – SPRIX inhibits platelet function and is CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of
• Cardiovascular (CV) Risk – NSAIDs may cause an increased risk of serious CV thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use.
Patients with CV disease or risk factors for CV disease may be at greater risk. SPRIX is CONTRAINDICATED for treatment of peri‐operative pain in the setting of coronary artery bypass graft (CABG) surgery.
• Renal risk – SPRIX is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion. Mild, transient nasal discomfort was the most frequently reported side‐effect of SPRIX use. SPRIX is contraindicated in patients with known hypersensitivity or a history of allergic reactions to aspirin, ketorolac, other NSAIDs or EDTA; in patients at risk for GI bleeding; prior to major surgery or during the perioperative period in CABG surgery; in patients with advanced renal disease or volume depletion; patients with certain bleeding risk and during labor and delivery. SPRIX should not be used concurrently with probenecid or pentoxifylline. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX.
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