ROXRO REPORTS FINDINGS FROM INTRANASAL ANALGESIC TRIAL

Roxro Pharma's investigational intranasal pain reliever has been shown to provide effective pain relief for patients who had undergone major surgery, according to new data presented at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine.

Patients who received ROX-888, an intranasal ketorolac, required significantly less morphine following surgery than patients who had access only to morphine, data from the Phase II study showed. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) most often administered as an intramuscular or intravenous injection.

The 127 patients enrolled in the double-blind, placebo-controlled study had undergone 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.

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