Pozen resubmits new drug application
07/16/2014 11:02 AM
07/16/2014 11:04 AM
Chapel Hill drugmaker Pozen announced Wednesday that federal regulators have accepted the resubmission of its new drug application for its heart attack and stroke-prevention pill.
Pozen was forced to resubmit its application after the U.S. Food and Drug Administration in April declined to approve the initial filing, citing deficiencies at a manufacturing facility where an active ingredient is produced. The announcement triggered a 10 percent one-day decline in Pozen’s stock.
The company said Wednesday it has since addressed the problem and refiled its application.
Pozen’s drug is an alternative to aspirin for treating heart-disease and stroke patients. Patients who have had strokes or heart disease are often prescribed aspirin to lower the risk of future complications, but taking traditional aspirin carries a high risk of stomach ulcers.
Pozen’s drug is a low-ulcer-risk aspirin that combines aspirin with instant-release of omeprazole. Omeprazole coats the stomach lining before the aspirin is released, minimizing the patient’s risk of developing ulcers.
The company’s application is for two doses of aspirin, 81 mg and 325 mg. Sanofi US is set to commercialize the product.
The FDA is expected to rule on the new application by December 30.
If approved, the drug will be Pozen’s third approved product in its portfolio. The company already markets the acute migraine treatment drug Treximet and arthritis relief drug Vimovo.
Pozen shares were down more than 6 percent mid-morning Wednesday to $8.26.
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