Nastech's safety issues

Second-guessing FDA requests for safety data is a risky strategy in getting drug approval - even for new formulations of drugs that are already on the market. Last week the FDA declined to accept an NDA from Nastech Pharmaceutical Co. Inc. for a nasally administered formulation of scopolamine to treat motion sickness, after the company provided less safety data than the agency had requested.

According to CFO Andy Zinzi, FDA wants to see safety data addressing "administration of the compound in a greater number of patients." While scopolamine is already marketed in tablet and transdermal patch formulations, "nasal administration has a rapid onset - therefore this raises safety issues," he said...