Roxro Pharma has received FDA approval for 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.
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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. The approval of Sprix provides acute pain outpatients with a non-narcotic and easy-to-administer alternative to commonly prescribed opioids.
Roberto Rosenkranz, CEO of Roxro Pharma, said: “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.
“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.”
Askomur Buvanendran, director orthopedic anesthesia at Rush University Medical Centers, said: “Sprix fills the need for a new non-opioid, non-injectable option for ambulatory pain control, because it minimises 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. The convenient nasal spray formulation will also provide pain relief outside of the hospital setting.”
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