APR Applied Pharma Research and Fidia Farmaceutici Receive IND Approval from FDA for a New NSAID Matrix Patch Product

The U.S. FDA has accepted the IND application for the development of a 140mg Diclofenac Sodium Matrix Patch for the topical treatment of acute pain

17/11/2008 - Company news

Applied Pharma Research sa (APR), and Fidia Farmaceutici SpA (Fidia) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for the development of a 140mg Diclofenac Sodium Matrix Patch for the topical treatment of acute pain due to minor strains, sprains and contusions.

The Diclofenac Sodium Matrix Patch uses a proprietary technology able to deliver the active ingredient directly to the affected area, thus providing sustained pain relief without the systemic exposure and GI side effects typical of oral NSAIDs or the cardiovascular risks associated with the Cox-2 inhibitors. The proprietary co-developed Matrix Patch technology has several advantages over conventional marketed hydrogel plasters, such as higher adhesive properties, elasticity (long and crosswise), minimal thinness, a superior high tech look as well as ease of use.

APR and Fidia are co-developing the product under a joint global partnership. In the United States, APR and Fidia intend to submit a 505(b)(2) NDA referencing the Flector® patch (diclofenac epolamine 1.3%) that was recently introduced into the market. The completion of the clinical development and filing of the dossier with the FDA is expected during Q1/2010.