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FDA Rejects Delayed-Release Aspirin/Omeprazole Tablets

Agency cites deficiencies at manufacturing facility

The drug candidates PA8140 and PA32540 (aspirin/omeprazole delayed-release tablets, Pozen Pharmaceuticals) have received a complete response letter (CRL) from the FDA. A CRL is issued when the review of the file is completed and questions remain that prevent the approval of the new drug application (NDA) in its current form.

In the CRL, the FDA noted that deficiencies were found during an inspection of the manufacturing facility of an active-ingredient supplier. Satisfactory resolution of deficiencies noted by the field investigator is required before the NDA may be approved. No clinical or safety deficiencies were noted with respect to either PA8140 or PA32540, and no other deficiencies were cited in the CRL. Final agreement on the draft product labeling is also pending.

Pozen Pharmaceuticals is developing investigational aspirin therapies with the goal of reducing gastrointestinal (GI) ulcers and other GI complications compared with taking enteric-coated or plain aspirin alone.

PA8140, containing 81 mg of aspirin, and PA32540, containing 325 mg of aspirin, are the first candidates developed by the company. Both products are tablets combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core. The patented product is intended for oral administration once a day.

An indication is being sought for the secondary prevention of cardiovascular disease in patients who require aspirin to:

  • Reduce the combined risk of death and nonfatal stroke for patients who have experienced ischemic stroke or transient ischemia of the brain because of fibrin platelet emboli
  • Reduce the combined risk of death and nonfatal myocardial infarction (MI) for patients with a previous MI or unstable angina pectoris
  • Reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris
  • Treat patients who have undergone a revascularization procedure (e.g., coronary artery bypass graft [CABG] or percutaneous transluminal coronary angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated
  • Decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers

Controlled studies with PA8140 or PA32540 tablets have not extended beyond 6 months.

Source: Pozen Pharmaceuticals; April 25, 2014.

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