MORAGA, CA, Feb. 6, 2014 – Trigemina, Inc., a biopharmaceutical company focused on the discovery and development of non-narcotic, nasally delivered, analgesic drug products, today announced it has expanded its Phase II clinical study for TI-001, intranasal oxytocin, beyond Chile to include sites in Brisbane and Adelaide, Australia.
“The expansion of the Phase II study to centers in Australia demonstrates the increasing excitement and support throughout the international community in addressing one of the most urgent global needs in drug development: a safe and effective therapy for chronic migraine,” said Charles Yeomans, President and Chief Executive Officer of Trigemina. “This progress will place us on track to complete enrollment of the trial in the second half of 2014.”
The Phase II TRIG-05 study is evaluating TI-001, an investigational, nasally-delivered oxytocin therapeutic being examined to determine its efficacy, tolerability, and safety in chronic migraine patients. Secondary endpoints in this study include determining the best Phase III dosage and exploring interlukin-6 (IL-6) levels as a potential biomarker for predicting efficacy. The TRIG-05 study is a placebo-controlled, double-blind, randomized-withdrawal and enrollment enriched clinical trial expected to enroll 96 patients. If approved by the U.S. Food and Drug Administration (FDA), TI-001 could be the first non-invasive treatment approved for chronic migraine, a debilitating condition affecting more than six million Americans.
Trigemina is a privately owned, clinical stage company focused on the discovery and development of non-narcotic, nasally delivered, analgesic drug products. Trigemina’s lead product candidate, TI-001, is a patented new application of oxytocin. TI-001 has shown promising results for use as a safe and effective therapy for most forms of chronic or subacute head pain.
The Ruth Group
Aaron Estrada (media)