Pozen’s MT nest

Pozen Inc. is on the way to becoming the poster child for the problems associated with the no research-development only (NRDO) business model, as it has now been turned down twice by the FDA for approval of reformulations or combinations of marketed drugs.

A not approvable letter issued by the FDA last week suggests that the agency does not think the company’s MT 100 - a combination of the approved drugs naproxen and metoclopramide - provides an improvement over naproxen, while it also is concerned with potential side effects associated with metoclopramide. ...