ARTICLE | Product Development
Noise nags tezampanel
October 29, 2007 7:00 AM UTC
TorreyPines Therapeutics Inc. is not sure why the two higher doses of tezampanel did not meet the endpoint in a Phase IIb trial for acute migraine pain, but the company will forge ahead with Phase III trials using the lowest dose, which did work. When tezampanel goes to FDA, the company believes the low dose's favorable safety profile and clear efficacy signal will outweigh the lack of a dose response.
TorreyPines (TPTX, San Diego, Calif.) also believes it can position the subcutaneous treatment for patients unable to tolerate an oral agent and those reluctant to use triptans because of cardiovascular risks. ...