News
IDEA AG announces successful completion of its pivotal Ph III study in Europe and reacquisition of rights to the targeted analgesic IDEA-033 in North America
IDEA AG today reports the positive outcome of another pivotal Phase III efficacy and safety study of the targeted analgesic product IDEA-033 in osteoarthritis (OA) of the knee in Europe.
The company simultaneously announces that it has gained exclusive control over the global rights to IDEA-033, after reacquiring for consideration the Northern American licence from its previous partner in the territory.
IDEA-033 was outlicensed in February 2003 to McNeil Consumer & Specialty Pharmaceuticals for the USA and Canada. The recent shift in the partner's focus to paediatric products provided IDEA with an opportunity to reacquire these IDEA-033 rights. IDEA now owns its lead product globally and will be able to enjoy the future world-wide profits or value generated from this first properly targeted local analgesic with blockbuster potential. The terms of the deal remain confidential.
IDEA-033 relies on the ultradeformable carrier (TransfersomeŽ) in a creamy suspension to deliver the broadly acting nonsteroidal anti-inflammatory drug (NSAID) ketoprofen into deep peripheral target tissues, such as muscles or joints. The carrier not only transports the drug through the skin barrier but also minimises local ketoprofen clearance through cutaneous blood microvasculature into systemic circulation. This increases and prolongs the local drug concentration in target tissue and minimises whole body exposure to the drug. Maximum local drug efficacy and product safety are thus achieved.
The large, multi-national, randomized, double-blind, parallel-group, placebo-controlled study was conducted in 32 centres in Germany, Poland, Croatia and Serbia. Its general aim was to confirm efficacy and safety of IDEA-033 used at three different doses during a 3 month OA treatment period. The specific primary study objective was to identify the dose(s) of IDEA-033 that significantly suppress the pain associated with OA of the knee.
A total of 866 subjects with osteoarthritis of one (47% of the total population) or two (53%) knees were enrolled in the study, and treated with 100 mg, 50 mg, or 25 mg of the drug per knee, or similarly dosed placebo, all twice per day. Pain reduction, as evaluated by the visual analogue scale version of the WOMAC, in the patient groups treated with the higher two doses of the study medication was statistically superior to placebo (p < 0.05 and p < 0.01, respectively) at the study end point of 12 weeks. Statistically significant treatment effects were observed after the first 24 hours of treatment (first time point of efficacy evaluation), as measured by the categorical version of the WOMAC (p < 0.01). Significantly more patients responded to IDEA 033 than to placebo for all 3 dosage groups investigated, according to the OMERACT-OARSI responder criteria. The patients completing the 3 month treatment period were allowed to continue the study for additional 3 months with the patients on IDEA-033 staying in their respective dosage group and the patients who were on placebo during the first 3 months being allocated to the appropriate IDEA-033 dosage group. Given that 511 patients have accepted the roll-over into the extension part of the study, IDEA will gain extended efficacy and safety data for the long-term use of IDEA-033 in OA.