FDA approves ROXRO PHARMA's SPRIX Nasal Spray

ROXRO PHARMA, Inc. (www.roxropharma.com) announced today that the U.S. Food and Drug Administration (FDA) has approved SPRIX™ (ketorolac tromethamine) Nasal Spray, for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.  SPRIX is a prescription intranasal formulation of the analgesic ketorolac, a non-steroidal anti-inflammatory drug (NSAID), designed to provide ambulatory patients with a convenient, potent, and fast-acting option for acute moderate to moderately severe pain relief.  Ketorolac tromethamine is a frequently administered non-narcotic injectable analgesic for moderately severe pain in U.S. hospitals today.  The approval of SPRIX provides acute pain outpatients with a non-narcotic and easy-to-administer alternative to commonly prescribed opioids.  

"The FDA approval of SPRIX provides an important new tool for physicians treating patients with moderate to moderately severe pain.  This is particularly significant at a time when patients and physicians have become increasingly concerned with use of narcotic pain relievers," said Roberto Rosenkranz, Chief Executive Officer of ROXRO.  "Currently approved injectable forms of ketorolac are already well accepted by the physician community for in-hospital use, so we believe uptake of this more convenient form will be rapid."  

"SPRIX fills the need for a new non-opioid, non-injectable option for ambulatory pain control, because it minimizes the potential for abuse as well as the negative side effects associated with narcotic pain relievers while providing potent control of moderate to moderately severe pain at the opioid level," said Askomur Buvanendran, Director Orthopedic Anesthesia, Rush University Medical Centers, Chicago, IL. "The convenient nasal spray formulation will also provide pain relief outside of the hospital setting."