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news.Roxro Pharma has received an Excellence and Innovation Award for the Phase III data of the company's novel intranasal pain reliever ROX-888, which is in development for the treatment of moderate-to-severe pain.
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The double-blind, placebo-controlled study 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 (30mg) 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.
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.
Roxro anticipates filing a new drug application with the FDA later this year for approval to market ROX-888. If approved, ROX-888 would be the first non-opioid intranasal analgesic.