LA JOLLA, Calif., Oct. 1 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that it held a successful End-of-Phase II meeting for tezampanel with the U.S. Food and Drug Administration (FDA) on September 29, 2008. Based on a review of the Phase II data, the FDA agreed that TorreyPines may initiate a Phase III program for tezampanel in acute migraine. The FDA also confirmed that the required thorough QT/QTc study for tezampanel can be conducted in parallel with the first Phase III pivotal trial. The timing for initiation of a Phase III trial is dependent on the company securing a development partner or funding for the program.
The FDA meeting follows the successful completion of a 306-patient, Phase IIb acute migraine trial that demonstrated a single 40 mg dose of tezampanel was safe, well-tolerated and effective in relieving headache pain at two hours post-dose. The Phase III clinical trial design for tezampanel will evaluate the 40 mg dose as well as a lower dose, consistent with the FDA recommendation that the lowest effective dose should be identified in the development of investigational drugs.
"We are pleased with the outcome of our meeting with the FDA and their
go-ahead for a Phase III program," said Ev Graham, acting chief executive
officer of TorreyPines. "This successful milestone, the first in a series
of clinical milestones we expect to meet this year, should significantly
help us achieve our strategy of securing a corporate partner or other
funding to continue development of tezampanel. We are also on track to
report by the end of the year, data from our ongoing Phase I study of
NGX426, the oral prodrug of tezampanel, in a capsaicin model of
hyperalgesia, as well as a Phase II study of
|SOURCE TorreyPines Therapeutics, Inc.|
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