According to the data of a phase II clinical trial reported at the 2011 World Congress on Osteoarthritis, nano-formulations of diclofenac offer better pain relief at lower-than-normal doses.
The diclofenac trial is part of Iroko Pharmaceuticals’ multi-drug development program to utilize proprietary nanotechnology for the reformulation of a wide class of pain relief drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Nano-formulations decrease the size of drug particles which in turn improve their dissolution in the body.
The multi-drug development program intends to utilize Iroko Pharmaceuticals’ proprietary SoluMatrix technology to reduce the dosages of NSAIDs and systemic exposure by 20% in order to enhance their tolerance and protection, while sustaining their efficiency. Standard Diclofenac formulations are NSAIDs that have been utilized as pain relievers for diseases such as osteoarthritis.
The standard dosages of diclofenac are 25 and 50 mg but the dosages of its nano-formulations presented at the Congress were 18 and 35 mg when compared to placebo. A significant finding was overall pain relief as informed at intervals more than 12 h (TOTPAR-12) by patients who suffered from severe dental pain due to third-molar removal. The study also showed statistically significant difference for nano-formulations in terms of improvement in pain relief. When compared with the pain reliever celecoxib with a dose of 400 mg, the nano-formulations demonstrated numerically better scores by TOTPAR-12 estimation.
The nano-formulations also demonstrated that they are statistically superior to placebo and numerically superior to celecoxib for TOTPAR assessment for 4 and 8 h. More findings of the Phase II clinical trials of nano-formulated NSAIDs being developed by Iroko will be reported at another important medical conference in 2011.
Source: http://www.iroko.com