ROXRO PHARMA Inc. said today
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.
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 pain conditions. The company's highly experienced staff engages a
global network of external experts to conduct pre-clinical and clinical
studies and to manufacture drug products. ROXRO plans to file with the FDA
for approval of its lead compound, ROX-888 in 2008.
ROXRO PHARMA Inc
roxropharma