Munich, Germany – IDEA AG today publicised two additional phase III clinical studies with Diractin® (ketoprofen in Transfersome® carriers, formerly known as IDEA-033) and successful completion of two long-term studies with the product.
In Q2 2008, IDEA started screening and enrolment for two additional phase III clinical trials in Europe (CL-033-III-03) and the USA (CL-033-III-06), to continue investigating the efficacy and safety of Diractin® for the treatment of osteoarthritis (OA) of the knee. In the European study, two dosages of the product are being tested against placebo and an oral comparator, celecoxib; in the USA, the study is only placebo controlled. The individual patient’s treatment period in both trials is three months. Enrolment for both studies should be finished by the end of this year. IDEA is also finalizing the analysis of a phase III, long term clinical safety and efficacy study that had been conducted in US. The study has enrolled 349 patients with OA of the knee and compared 100 mg ketoprofen in Diractin® applied epicutaneously with 500 mg naproxen given orally, both twice daily, over a treatment period of 12 months. Another study in reporting is a European phase III, open-label, long term safety and efficacy trial that had enrolled 487 patients, who were treated with Diractin® for a period of up to 36 months.
Data from both recently finished and the results from the two ongoing clinical studies with Diractin® will be used in the new application to the EMEA for Community Marketing Authorisation of the product, to be submitted in 2009.
Gregor Cevc, IDEA’s founder and CEO, commented: “After having now determined that EMEA wants to review data from all clinical studies with Diractin®, finished as well as ongoing, we will continue using best efforts to ensure their timely availability. Our present understanding of the data justifies an optimistic look forward to the final success of Diractin® both with regulators and in the marketplace, where the product could meet a large medical need.”
For further information, please contact:
Prof. Gregor Cevc PhD
Tel.: +49 (172) 8386267
Matthias Rother, MD, PhD
Exec. Head of Medical Development
Tel.: +49 (174) 1789457