The study is designed to provide additional data, if required, by the US Food and Drug Administration (FDA) for the approval of RHUCIN at the 50 U/kg dose.
Data from the study will also be used to provide additional validation of the visual analog scale used in measuring the clinical effects of RHUCIN.
The international, multicentre, randomised, placebo-controlled Phase IIIb clinical study will enrol approximately 50 patients.
The safety and efficacy of RHUCIN for the treatment of HAE attacks was previously assessed in two randomised placebo-controlled studies and four open label treatment studies.
The two placebo-controlled clinical studies showed statistically significant and clinically relevant improvement in the primary endpoint which was defined as of time to beginning of relief of symptoms compared to placebo.
In October 2010, Pharming had received Marketing Authorization in the European Union for RUCONEST (RHUCIN in non-European territories) for the treatment of acute angioedema attacks in patients with HAE.
Santarus has licensed certain exclusive rights from Pharming to commercialise RHUCIN in North America for the treatment of acute attacks of HAE and other future indications.