The price of fine tuning

Companies often have logical reasons for making modifications to products in the midst of clinical trials. Nevertheless, the process is fraught with peril - primarily the risk that the FDA will ask for trials with the new product, delaying approval.

The FDA's non-approvable letter to Dura Pharmaceuticals Inc. and its Spiros Development Corp. II R&D company served as a reminder last week that even small changes in a study can affect the regulatory outcome. When DURA submitted its NDA for Albuterol Spiros, an inhaler powder form of the widely used asthma drug albuterol, the regulatory hurdles seemed low. But the FDA's request for additional trial data now means that the company could forego as much as $30 million in anticipated sales of the product next year...