| GENERIC NAME | This data is not available for free |
| INDICATION'S | This data is not available for free |
| OBSERVATION'S |
The formulation is an improved delivery vehicle for the oral delivery of amlexanox which potentially overcomes the difficulties encountered in using conventional paste and gel formulations for conditions in the mouth. These products are difficult to apply and keep in place over time. The mucoadhesive disc adheres to the canker sore and slowly erodes over time, locally releasing amlexanox at the site of the canker sore. Utilizing this technology, we anticipate that higher drug concentrations will be achieved at the disease site increasing the effectiveness of the product. In 2001, the results of our initial Phase III study were reported, confirming the effectiveness of the product. In the study, three groups were evaluated, approximately 160 patients were treated with active, while 160 patients received a placebo disc and 80 patients received no treatment. Compared with both the placebo and no treatment groups, the primary clinical endpoint which evaluated complete healing on day 5 was achieved, with accelerated healing with active being statistically significant. Prior to initiating the final Phase III study, and the submission of a new drug application, Co. has evaluated alternative disc technologies to ensure that the final product can be manufactured efficiently and that the process can be scaled for commercial production. This evaluation has been concluded and the clinical trial materials have been produced at a contract manufacturing location which could be the source of the commercial product. A meeting has been conducted with the FDA to determine the clinical study requirements to file a new drug application. A 700 patient clinical study, with three groups; active treatment, placebo and no treatment, will be required prior to filing for product approval. This study is scheduled to commence in the second-quarter 2002 and be completed prior to year-end. We plan to submit the new drug application as soon as the clinical trial report is completed. It is anticipated that the full-market potential for amlexanox for the treatment of canker sores will only be realized when active is approved as an over-the-counter product, not requiring a prescription. The timing of achieving this objective is currently being evaluated, considering the regulatory requirements and the most advantageous way to develop the commercial potential. Establishing a solid base of professional endorsement for the use of amlexanox for the treatment of canker sores is considered an important component of an overall consumer marketing strategy |
| UPDATE | 12.05 |
| BUSINESS ACQUISITIONS | This data is not available for free |
| COMPANY | This data is not available for free |
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