Orexo initiates OX51 Phase II trial in patients undergoing prostate biopsy

Swedish specialty pharmaceutical company Orexo (STO:ORX) today communicated the start of the dose finding study for OX51 in patients undergoing prostate biopsy. Results from the study, which is a European study enrolling approximately 200 patients, will be available during the first half of 2013.

OX51 is a novel breakthrough innovation from Orexo, which has been developed to meet the fast growing demand for efficient pain management during short-term surgical and invasive diagnostic procedures. OX51 is a sublingual formulation of alfentanil, based on the leading sublingual delivery technology developed by Orexo. The quick onset, short duration, rapid offset and convenient administration of OX51 make it suitable for prevention of pain during a multitude of procedures.

The market for short-term surgical and diagnostic procedures is large and growing with over 130 million procedures performed annually in the US and EU. The growth is driven by both improvement in technology, and a result of an increasing cost control, which propels a shift in such procedures from an in-patient/hospital setting towards an outpatient setting. This shift has created a major need for improving efficient pain management during the short-term surgical and diagnostic procedures without the full access to all resources otherwise found in a hospital.

"OX51 is yet another innovation from Orexo providing the first oral formulation of alfentanil and meeting a fast growing need from patients and health care providers. Feedback from doctors is universally positive to the product characteristics of OX51 and we move forward in the development of this highly innovative product with great confidence," said Anders Lundström, CEO. "The dose finding study will enable Orexo to decide the best possible development strategy for phase III, which we expect to communicate during first half of 2013 once the trial has been completed".