Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

May 26 2010

Trigemina, Inc. (TI), a Mountain View based privately-held biopharmaceutical company, reports positive results from a time-based interim analysis of its Phase IIa clinical trial in Chronic Daily Headache (CDH). The trial is a collaborative effort between Trigemina and Dr. Egilius Spierings of MedVadis Research Corporation located outside of Boston. The study compares intranasal oxytocin with placebo in patients suffering from CDH.

“Based on the data to date, we believe intranasal oxytocin shows promising efficacy. We are demonstrating that intranasal oxytocin has the potential to significantly reduce pain in CDH patients and improve the lives of millions of people suffering from this debilitating condition.”

CDH represents approximately 3% of the US population for which there currently is no effective treatment. TI exploits a recently elucidated nasal-cerebral drug delivery route for targeting pain transmission in cranial nerves and the CNS, enabling vast new possibilities for the treatment of acute and chronic pain.

To date, 25 CDH patients refractory to available medication have been analyzed after intranasal oxytocin or placebo in a double blind, parallel trial. The data show 47% of oxytocin treated patients versus 11% of placebo patients reporting at least a 50% reduction in pain scores. Trigemina CEO Daniel Jacobs, MD stated, "Based on the data to date, we believe intranasal oxytocin shows promising efficacy. We are demonstrating that intranasal oxytocin has the potential to significantly reduce pain in CDH patients and improve the lives of millions of people suffering from this debilitating condition."

SOURCE Trigemina, Inc.