LAST PATIENT ENROLLED: EUROPEAN PHASE III PIVOTAL TRIAL COMPLETED
Medical Developments International Limited (ASX: MVP) is delighted to confirm the 300th and final patient has been enrolled into its European Phase III trial. The trial commenced in August of 2011 and has successfully completed on time and on budget.
The Phase III trial is a randomized, double blind, multi-centre, placebo controlled study to evaluate the safety and efficacy of Penthrox for the treatment of acute pain in patients presenting to an Emergency Department with minor trauma. The trial was conducted at six hospital sites in the United Kingdom.
MVP CEO Mr. John Sharman said “After collation of the data from the trial it will be used to support an application to obtain Marketing Approval in selected European countries. We expect to finalise our European Marketing Approval application sometime in Q3FY2013. If our MA is successful the opportunity to sell Penthrox in Europe is significant.”
MVP Chairman, Mr. David Williams said “In recent years Penthrox has received registration in 10 countries and orders are building from a zero base. However the possibility of supplying into Western Europe is the most exciting prospect the company has had in years. This is the first time the company will have “world class” European clinical data to support its registration and use in Western European markets.”
Mr. Sharman, said that “while this is an important milestone for the company, it is also a very big endorsement for Australian ambulance officers who have supported the product for many years. They can take credit for Penthrox now being used in 10 other countries and for the trial that has taken place in the Accident and Emergency departments of six UK hospitals and the prospects that holds”.