Pozen Continues Discussions with the FDA - Drug Discovery and Development

Pozen Inc. claims it is making progress in discussions with regulators about its experimental cardiovascular drug PA32540.

Pozen said the Food and Drug Administration appeared to be satisfied with the additional data it submitted in support of PA32540. Earlier this year, the FDA asked Pozen to do a study that would measure the bioequivalence of Pozen’s treatment compared to aspirin. The company said the FDA appears to be satisfied with its additional data even though it has not yet performed that study.

The FDA has not yet made a final determination on the additional data the company has submitted. The agency wants to confirm that PA32540 and aspirin show up in patients’ blood streams at similar rates after patients take the drugs.

The Chapel Hill, N.C., company also said it expects to file for approval of a lower-dose version of PA32540 in the first half of 2013. The FDA has agreed to give Pozen feedback as it prepares to make that filing. The lower-dose version is designated PA8140.

The drug is intended as an alternative to aspirin as a secondary treatment for the prevention of cardiovascular disease. Many people take aspirin to prevent heart problems, but long-term use of aspirin can cause ulcers. PA32540 contains aspirin and omeprazole, the active ingredient in heartburn drugs like Prilosec. The omeprazole is released as soon as the drug is taken and the aspirin is released over time.

PA32540 contains 325 milligrams of aspirin and 40 grams of omeprazole, and the company is now developing a version with 81 milligrams and aspirin and 40 milligrams of omeprazole. The FDA encouraged Pozen to study the lower-dose version and said it might only approve the larger-dose version for limited groups of patients.

Date: August 24, 2012
Source: Associated Press