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Roxro Pharma's Novel Intranasal Analgesic Provides Effective Pain Relief, New Data Show

Patients Using Roxro's Pain Reliever Required Significantly Less Morphine After Major Surgery

SAN FRANCISCO, CA -- November 16, 2006 -- Roxro Pharma Inc.'s novel intranasal pain reliever has been shown to provide effective pain relief for patients who had undergone major surgery, according to new data presented here today at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine.

Patients who received ROX-888 -- Roxro Pharma's intranasal ketorolac -- required significantly less morphine following surgery than patients who had access only to morphine, data from the Phase 2 study showed. Ketorolac is a nonsteroidal anti-inflammatory medicine most often administered as an intramuscular or intravenous injection for the short-term treatment of moderate to severe pain.

"This study shows that ketorolac (30 mg), in an easy-to-use nasal spray, not only provides patients with potent pain control, but also reduces the need for morphine following surgery," said Dr. Colin Brown, lead investigator and executive director of Waikato Clinical Research in Hamilton, New Zealand. "At the 30 mg dose, intranasal ketorolac appears to be as potent and as rapidly acting as the injectable," he said.

The 127 patients enrolled in the double-blind placebo-controlled study had undergone primarily either orthopedic or abdominal surgery. Patients were assigned to receive intranasal ketorolac (10 mg or 30 mg) or placebo. All study participants had access to patient-controlled morphine.

Patients who received placebo on average required 56.5 mg of morphine in the first 24 hours following surgery. Ketorolac (30 mg) patients used on average 37.8 mg or 34 percent less morphine in the same time period.

Patients were assessed at regular intervals throughout a 48-hour period after surgery and rated their pain intensity on a widely accepted visual analog scale. Ketorolac (30 mg) patients not only required significantly less morphine, they also rated the quality of their pain relief as superior to patients who received only morphine.

Intranasal ketorolac was well tolerated by patients. The incidence of side effects was similar between the ketorolac and placebo groups.

"Pain severity and the quality of pain control significantly favored the 30-mg ketorolac group over both the low-dose ketorolac (10 mg) group and the placebo group," Dr. Brown said. "Injections can be very inconvenient, so there is a need for novel delivery of pain relievers, particularly as a practical alternative to shots in the ambulatory setting."

"We're very excited that our convenient nasal spray has been shown to be as potent as injectable ketorolac," said Roxro Pharma Chief Executive Officer Roberto Rosenkranz. "ROX-888 is a significant medical advance for patients seeking comfortable and effective pain relief. We are moving quickly to bring to patients this new medicine, which we expect will be the very first non-opioid intranasal analgesic."

Roxro Pharma expects the intranasal ketorolac Phase 3 program to be completed in the first quarter of 2007.


SOURCE: Roxro Pharma Inc.

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