Pozen's PA8140/PA32540 Receives Complete Response Letter From FDA

(RTTNews) - Pozen Inc. (POZN) said Friday that its drug candidates PA8140/PA32540 delayed release tablets have received a complete response letter from the U.S. Food and Drug Administration.

PA8140/PA32540 Tablets contain 81 mg or 325 mg delayed release aspirin and 40 mg immediate-release omeprazole and are indicated for patients who require aspirin to reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, to reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris, in patients who have undergone revascularization procedures when there is a pre-existing condition for which aspirin is already indicated, and to decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers.

A complete response letter is issued by the FDA when the review of the file is completed and questions remain that preclude the approval of the new drug application in its current form.

In the complete response letter, the FDA noted that, during an inspection of the manufacturing facility of an active ingredient supplier that concluded this week, inspection deficiencies were found. Satisfactory resolution of deficiencies noted by the field investigator is required before the NDA may be approved.

The company believes that those manufacturing facility items can be addressed and will be working with the manufacturer to respond to the FDA as soon as possible.

There were no clinical or safety deficiencies noted with respect to either PA8140 or PA32540 and no other deficiencies were noted in the complete response letter, Pozen said.

Final agreement on the draft product labeling is also pending.