June 7, 2007 — ROXRO PHARMA Inc. announced that ROX-888, its novel intranasal analgesic, rapidly and effectively eased pain and was well tolerated by patients who had undergone major abdominal surgery in a Phase 3 clinical study.
"This completes our second and final Phase 3 clinical study," said ROXRO PHARMA's Chief Scientific Officer Roger Whiting. The company intends to include fully analyzed data in its New Drug Application for submission to the U.S. Food and Drug Administration. "We are very pleased with the solid results of this Phase 3 study and are on track to file our NDA in the first half of 2008," Whiting said.
In the Phase 3 study, patients who received ROX-888 reported greater improvement in pain relief and required 22 percent less morphine in the first 24 hours following surgery compared to patients who had access to morphine alone. 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 moderately severe pain.
"ROX-888 is an important breakthrough in treating pain," said Dr. Neil Singla, Director of Clinical Research at Huntington Memorial Hospital in Los Angeles. "It is rapidly absorbed into the bloodstream, and relieves pain as fast as an intramuscular injection. There is a need for new analgesics like ROX-888 that do not have the troublesome side effects and abuse risks associated with narcotic pain relievers."
The Phase 3 double-blind, placebo-controlled study included 321 patients who had undergone major abdominal surgery. Patients were randomized to receive either intranasal ketorolac (30 mg) or placebo. All study participants had access to patient-controlled morphine.
"Pain is at its greatest intensity in the first 24 hours following surgery," Dr. Singla said. "With the continued increase in out-patient surgeries, there is a growing need for alternatives to injections and intravenous administration of pain killers."
ROX-888 is contained in an easy-to-use nasal spray for self-administration by patients when they require pain relief. "This would be particularly convenient in the ambulatory setting," Dr. Singla said.
If approved, ROX-888 would be the first non-opioid intranasal analgesic indicated for the treatment of acute pain. "We are eager to bring a novel pain treatment option to patients" ROXRO's Whiting said.
For more information visit: www.roxropharma.com