TORREYPINES BEGINS TRIAL OF TEZAMPANEL IN ACUTE MIGRAINE

TorreyPines Therapeutics has begun a Phase IIb trial of its lead product candidate, tezampanel, a novel pain compound in development for the treatment of acute migraine. An AMPA/kainate (AK) receptor antagonist, tezampanel offers a non-narcotic, non-vascular approach to the management of headache pain and represents a potentially promising alternative to current migraine treatments, according to the company.

The double-blind, placebo-controlled, parallel-group study will enroll approximately 300 patients and treat a single migraine attack, with or without aura. Equal numbers of patients will be randomized to one of four arms and receive a 40-, 70- or 100-mg single subcutaneous dose of tezampanel or placebo. The primary efficacy endpoint is headache pain relief at two hours after the dose. Secondary efficacy endpoints include sustained pain relief at 24 hours and headache recurrence and relapse. Additional measures include assessments of functional disability and patient satisfaction, relief of migraine-associated symptoms such as nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound), as well as various assessments that characterize speed of onset. Safety, tolerability and pharmacokinetics will also be evaluated. The study will be conducted in approximately 25 centers in the U.S.

In previous clinical trials, tezampanel has been administered to more than 200 healthy adult volunteers. In five Phase IIa, placebo-controlled trials, tezampanel demonstrated proof of concept in multiple pain models. In a placebo and active-controlled trial in patients with acute migraine, the compound, administered intravenously, achieved statistical significance in all primary and secondary endpoints traditionally required for regulatory approval. These endpoints included pain relief at two hours and relief of nausea, photophobia and phonophobia.