• Dermisonics (West Conshohocken, Pennsylvania), focused on developing an ultrasonically assisted transdermal drug-delivery technology, said that the U.S. Patent and Trademark Office has issued a notice of allowance for the approval of the most substantial patent claims for the Medi-Cap, a transdermal drug-delivery device. The Medi-Cap is a two-part transdermal patch system consisting of a Transducer Coupler and a Patch-Cap, which contains the drug itself, suspended in liquid. It is designed for ultrasonic and other electronic drug delivery applications where a conventional patch is unsuitable, due to reliance on a mixture of the drug and an adhesive substance. The Patch-Cap portion of the Medi-Cap uses an absorbent pad to store the drug until ultrasound, delivered from the snap-on Transducer Coupler, liberates the drug onto the patient’s skin surface. Then ultrasound can be employed to dilate the skin pores and deliver the drug into and through the in vitro dermis. The Transducer Coupler contains up to four miniature ultrasonic transducers and is powered by the U-Strip Ultrasonic Drug Delivery System. The design can hold up to 75 units of insulin.
• Draxis Health (Mississauga, Ontario) said preliminary results from its Canadian trial indicate that Fibrimage imaged deep vein thrombosis (DVT) but that the review of patient data and charts is required to complete analysis of the trial. The target for filing a new drug submission (NDS) in Canada has been moved to the second half of 2005, pending the outcome of the analysis. The primary endpoint in the trial was the accuracy of Fibrimage for detecting a DVT vs. the defined “truth standard.” The preliminary results from the Canadian trial indicate that Fibrimage successfully imaged DVT in patients with clinical symptoms that raised concern as to the presence or absence of DVT. Additionally, a Phase III clinical trial of Fibrimage in Canada closed in late 2004, and the first readings of scans were completed during the first quarter of 2005. Fibrimage was administered as a single intravenous injection and images of suspected sites of DVT in each patient’s legs were taken using a gamma camera. The scans for each patient in the trial were benchmarked against the clinical assessment algorithm and the results of ultrasound evaluation. Draxis provides specialty pharmaceutical products in three categories: sterile products, non-sterile products and radiopharmaceuticals.