One new drug set aside, another on the way…
Pozen, Inc. has decided to stop developing its new migraine drug, MT 100. The Naproxen Sodium and Metoclopramide Hydrochloride drug needed more trials, the FDA concluded. There have been concerns that it may cause tardive dyskinesia, a chronic disorder of the nervous system causing jerky movements in the face, tongue, and other parts of the body.
However, yesterday Pozen announced it was going to focus on another new drug, Trexima. Trexima is a combination of sumatriptan (formulated with "RT Technology") and naproxen sodium. So far the trials are going well, and Pozen is hoping to make the drug available as soon as possible. The ingredient in MT 100 that was causing concern, metoclopramide, is not present in Trexima. Sumatriptan and naproxen sodium are familiar to migraineurs. RT technology has been used with Imitrex – it allows the drug to dissolve very quickly after swallowing, getting it into the body where it’s needed much faster.
daisy
13 June 2006 @ 8:07 pm
does the full approval is delayed for months-even yeans if the FDA requires safety information?