Roxro Pharma’s Novel Intranasal Pain Reliever Effective, Well
Tolerated in Phase 3 Study
Patients Using ROX-888 Required Significantly Less Morphine After
Major Abdominal Surgery Company On Track To File NDA In 2008
MENLO PARK, CA (June 6, 2007) – 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. # # #
Posted: June 2007
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