The FDA raised its concerns over a component of MT100, metoclopramide hydrochloride, which has been associated with tardive dyskinesia, an involuntary neurological movement disorder.
The advisory committee voted that the potential, but unquantified, risk for tardive dyskinesia would outweigh the benefits, of metoclopramide hydrochloride in combination with naproxen sodium. However, the company has not been as disheartened as it might have been as it has high hopes for its other migraine drug, Trexima, which has been licensed to pharmaceuticals giant GlaxoSmithKline. As such, the effect on the company’s share price has been minimal so far.
“Based on a thoughtful review of the outcome of yesterday’s meeting, we have decided to discontinue further development of MT100 in the US,” said Dr John Plachetka, Pozen’s chairman, president and CEO. “Part of the reason for this is that we expect to file the Trexima new drug application (NDA) shortly, and Trexima has already demonstrated greater efficacy without the metoclopramide risk associated with MT 100.”