has ended its planned development of one proposed painkiller in order to pursue another more promising medication.
The risks of the experimental migraine drug MT 100 outweighed its benefits, according to the Food and Drug Administration's advisory committee for peripheral and central nervous system drugs, which met yesterday. The company received a "not approvable" letter from the FDA for the treatment in May 2004.
The FDA committee met specifically to discuss the risk of involuntary movements of the tongue, lips, face and body, called tardive dyskinesia, which is associated with the use of metoclopramide hydrochloride, one of the components of MT 100. These symptoms are also associated with the use of older antipsychotic drugs.
Pozen, of Chapel Hill, N.C., intends to pursue Trexima, which it licensed to
for commercialization in the U.S.
"Part of the reason for this is that we expect to file the Trexima NDA shortly, and Trexima has already demonstrated greater efficacy without the metoclopramide risk associated with MT 100," said Pozen Chairman, President and CEO John Plachetka.
Pozen shares were up 3 cents to $8.