1:28AM Santarus and Pharming announce positive top-line Phase III results for RUCONEST in acute hereditary angioedema (SNTS) 9.17 : Co and Pharming Group NV announce that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema met the primary endpoint of time to beginning of symptom relief. A statistically significant difference in the time to beginning of symptom relief was observed in the intent-to-treat population between RUCONEST and placebo; the median time to beginning of symptom relief was 90 minutes for RUCONEST patients and 152 minutes for placebo patients. The time to beginning of symptom relief was defined as the time from the beginning of infusion of study medication until the beginning of a persistent beneficial effect, based on the patient's responses to a Treatment Effect Questionnaire for the primary attack location. RUCONEST was generally well tolerated in this Phase III clinical study and the frequency of patients experiencing at least one treatment emergent adverse event in the RUCONEST treated group was less than in the placebo group. Within 72 hours of the completion of infusion of study medication, four RUCONEST patients (7%) experienced six adverse events: sneezing, procedural headache, back pain, skin burning sensation, an increase in fibrin D-dimer and lipoma. Within the 72 hour period four placebo patients (22%) experienced four adverse events: sinus congestion, vasomotor rhinitis, diarrhea and dyspepsia.
