TransDermal Ibuprofen Development Complete: NDA To Be Filed
Thursday December 16, 1:15 pm ET
WELLESLEY, Mass., Dec. 16 /PRNewswire/ -- TransDermal Systems, a subsidiary of Strategic Science & Technologies of Wellesley, MA announced today the completion of the research and development work on its transdermal ibuprofen preparation. The product is based on the company's proprietary transdermal delivery platform forms an environment in the vehicle that is biophysically hostile to ibuprofen. This hostile environment causes ibuprofen to prefer to move from the vehicle into the tissue to which it is applied.
The company intends to seek a New Drug Application (NDA) under section 505 (b) (2) of the Federal Food, Drug, and Cosmetic Act for approval of their product as a new dosage form of ibuprofen. Oral administration of ibuprofen is often contraindicated since it can lead to gastro-intestinal (GI) bleeding. In the US approximately 100,000 hospitalizations and 10,000 deaths result each year from oral ibuprofen administration. Although COX-2 inhibitors such as Vioxx and Celebrex were initially developed to avoid the GI bleeding problem, the removal of Vioxx from the market and the suspicion cast on other COX-2 inhibitors by the Vioxx situation has created a market need for a product that can safely relieve joint and muscle pain. Health professionals fear that increased use of ibuprofen by patients formerly taking COX-2 inhibitors will further increase the incidence of hospitalization and death from GI bleeding. Use of transdermal ibuprofen could drastically reduce those hospitalizations and deaths.
A major advantage of transdermal administration of drugs that act locally, such as ibuprofen, is a dramatically reduced total dose of the drug. For example, if 400 mg of an oral anti-inflammatory were required to treat wrist pain systemically, the same relief would be achieved by applying only 1/2 mg of the drug transdermally, directly to the wrist. The resultant 800-fold reduction in total dose of the drug should result in a major reduction in unwanted side effects such as GI bleeding. A company spokesperson went on to suggest that similar reduction in adverse events could result from the transdermal delivery of COX-2 inhibitors due to the drastic reduction in total dose.
The spokesperson emphasized that its transdermal ibuprofen product is not commercially available and will only become commercially available if and when the FDA approves the NDA that the company will submit.
For further information contact Catherine Maker at Strategic Science & Technologies LLC, 892 Worcester Road, Wellesley, MA 02481. 781 416 3777 or cmaker@strategicsci.com. |
