ROXRO PHARMA's Phase 3 Intranasal Analgesic Data Receives Excellence Award
Monday May 5, 8:00 am ETÂ
Data Presented at the Society for Ambulatory Anesthesia Annual Meeting
MENLO PARK, Calif., May 5 -- ROXRO PHARMA, Inc. today announced it has received an Excellence and Innovation Award for the Phase 3 data of the company's novel intranasal pain reliever ROX-888, which is in development for the treatment of moderate-to-severe pain.
The award was presented by the Committee on Scientific Papers of the Society for Ambulatory Anesthesia on Sunday, May 4, in Miami, where the organization's annual meeting was held. Dr. Harold Minkowitz, of the Dept. Anesthesiology at Memorial Hermann Memorial City Medical Center in Houston, TX, presented a poster summarizing the ROXRO data during the three-day meeting.
"We are especially pleased that our work has been recognized by this important medical organization," said ROXRO chief executive officer Roberto Rosenkranz. "This award recognizes our innovative approach to meet the unmet need to deliver the well established pain reliever ketorolac to ambulatory patients who wish to avoid opiate side effects."
ROX-888 is an intranasal formulation of ketorolac, a non-steroidal anti-inflammatory medicine most often administered as an intramuscular injection or intravenously for the short-term treatment of moderate-to-severe pain.
The double-blind placebo-controlled study detailed in the award-winning poster showed that ROX-888 rapidly and effectively eased pain among patients who had undergone major abdominal or orthopedic surgery. In addition, ROX-888 significantly reduced the need for morphine among these patients. Patients who received ROX-888 (30 mg) rated the quality of their pain relief as superior to patients who received only morphine. The study enrolled 321 patients whose pain was assessed at regular intervals in the first 48 hours following surgery. Side effects were similar between the ROX-888 and placebo groups.
Because ROX-888 is formulated as an easy-to-use nasal spray, patients can exercise good control over their pain relief. In addition, the formulation makes ROX-888 an attractive analgesic option in the out-patient, or ambulatory setting.
ROXRO anticipates filing a New Drug Application with the U.S. Food and Drug Administration later this year for approval to market ROX-888. If approved, ROX-888 would be the first non-opioid intranasal analgesic.
ABOUT ROXRO PHARMA
ROXRO PHARMA, Inc., of Menlo Park, Calif., is a privately owned specialty pharmaceutical company focused on the treatment of pain. Founded in 1999, ROXRO in-licenses promising drug candidates for rapid development in acute medical conditions. The company's highly experienced management team engages a global network of external experts to conduct pre-clinical and clinical studies and to manufacture drug products. ROXRO's lead compound, ROX-888, has completed Phase 3 trials for the treatment of acute moderate-to-severe pain. The company's earlier pipeline includes a Phase 2 compound for migraine and a pre-clinical compound for neuropathic pain.