The plan consists of three phase III efficacy trials, the first of which is currently ongoing in knee osteoarthritis in the US, with an additional, similarly designed knee study expected to start in the first quarter of 2007. This will be followed by the initiation of a hip osteoarthritis trial in the third quarter of 2007.
In addition, Nicox is providing new information on the clinical studies it plans to conduct to confirm naproxcinod’s superior blood pressure control and gastrointestinal safety and tolerability profile, compared to existing anti-inflammatory agents.
These safety assessments will calculate blood pressure by using controlled blood pressure measurements. Nicox plans to assess gastrointestinal safety and tolerability by conducting a clinical endoscopy study with the objective of confirming the previous clinical findings that naproxcinod treatment results in less gastro-intestinal damage than naproxen.
Naproxcinod is the first in a new class of anti-inflammatory with the potential to become the drug of choice for osteoartritis.
“The senior management of Nicox believes that the phase III efficacy plan we are presenting today for naproxcinod will allow us to gain an indication for treating the signs and symptoms of osteoarthritis in the territories where we have held regulatory discussions,” commented Staffan Stromberg, vice president of Drug Development at Nicox.
Millions of people rely on non steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors as the only available drugs to treat chronic pain and inflammation associated with osteoartritis and a range of other serious conditions. However these products are associated with a low but significant incidence of serious side effects, such as cardiovascular and gastrointestinal complications, which can be life threatening in some cases.
The preclinical and clinical studies conducted to date suggest that naproxcinod possesses an improved blood pressure control and gastrointestinal safety and tolerability profile, compared to existing NSAIDs, due to nitric oxide donation.
Nicox anticipates that regulatory submissions in the US and Europe may be submitted during the first quarter of 2009, subject to any additional requirements from regulatory authorities.
Based on discussions with the FDA and regulatory authorities in the UK and Sweden, NicOx believes that its phase III plan, outlined above, will be adequate to satisfy current requirements in the US and European Union (EU) with regards to demonstrating the efficacy of naproxcinod for treating the signs and symptoms of osteoarthritis.
The agencies in Sweden and the UK have also advised the company that under current EU requirements the safety of naproxcinod should be assessed according to the standard ICH guidelines, which implies that a long-term cardiovascular safety study would not be required to gain marketing authorization in these territories. Nicox has also requested scientific advice on naproxcinod from the European Medicines Agency.
Discussions with the FDA are continuing concerning the requirements for long-term safety data needed for the approval of naproxcinod in the US In August 2006, Nicox submitted documentation to the FDA regarding naproxcinod and is awaiting the agency’s comments on this package.
Moreover, Nicox plans to validate a proposed development for Japan with the Japanese authority in the first quarter of 2007.