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Cardium Announces Plans to Acquire Transdel Pharmaceuticals Phase 3 Topical Analgesic and Cosmeceutical Business Assets
Date:6/27/2011

rheumatoid arthritis, as well as traumatic pain in patients with soft-tissue injuries or back injuries.   While there are orally administered ketoprofen-based products registered for marketing and sale in the United States, there are no topical ketoprofen-based products available in the U.S.  Corresponding clinical studies have been based on an FDA Section 505(b)(2) registration pathway.  

Although ketoprofen has been available as a prescription pill, orally-administered NSAIDs reach their target site in the musculoskeletal tissue only after entering the systemic circulation which can lead to side effects limiting their use.  The withdrawal from the market of various orally-administered pain medications such as Cox-2 inhibitors (as a result of gastrointestinal, cardiovascular and other side effects) has removed major therapeutic treatment options for patients with moderate to severe pain, and has led to increased interest in NSAIDs that can be delivered locally to the target tissue, thereby lowering the systemic concentration.  In a recent study published in the journal of the American Association of Pharmaceutical Scientists comparing topical to oral administration of ketoprofen, it was reported that topical administration could achieve comparable levels of tissue concentration with a 17-fold lower plasma concentration. Sekiya, I. et al., "Ketoprofen Absorption by Muscle and Tendon after Topical or Oral Administration in Patients Undergoing Anterior Cruciate Ligament Reconstruction," AAPS PharmSciTech 11:154-158 (2010).

Cardium believes that with FDA registration, Ketotransdel would offer a new analgesic option within the topical NSAID market, which is now estimated to exceed $200 million annually in the United States.  Currently-available products for use in the U.S. include such third party products as the Flector® Patch (sold by King Pharmaceuticals under license from IBSA), Voltaren® Gel
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SOURCE Cardium Therapeutics
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