The placebo-controlled trial enrolled 110 healthy adult males at one center in the US. The primary purpose of the study was to investigate the safety, tolerability and pharmacokinetics of tezampanel in healthy volunteers.
Tezampanel, administered subcutaneously, was well tolerated at single doses up to and including 100mg and pharmacokinetic findings showed the compound was rapidly and completely absorbed.
The company now plans to move forward with a phase II clinical trial during the second half of this year.
Tezampanel, an AMPA/kainate (AK) receptor antagonist, offers a non-opioid, non-vascular approach to the management of migraine and other persistent pain states and represents a promising alternative to current treatments.
“We are pleased with the results of our phase I study and we look forward to initiating a phase II program evaluating subcutaneous administration of tezampanel in the treatment of acute migraine,” said Dr Neil Kurtz, president and CEO of TorreyPines. “With its previously established efficacy when given intravenously, this compound has the potential to offer migraine sufferers the first novel alternative to their pain management in more than a decade.”