Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Clinical Data is starting patient enrollment in a pivotal phase III clinical trial for vilazodone, a novel compound being studied for treatment of depression, and anticipates having initial results from this study available by mid-2007.
Subscribe to our email newsletter
The successful outcome of this trial would serve as one of two pivotal trials required for a new drug application, which the company hopes to file with the FDA before the end of 2008.
The company also plans to use information from the trial to develop a companion biomarker test that will predict how well patients will respond to the drug.
According to Dr Carol Reed, chief medical officer of Clinical Data, about half of depressed patients do not achieve satisfactory results with current first-line treatment options. As such, the company hopes that the test it is developing will assist physicians in matching a patient with a treatment that is likely to work for that patient. There are no such predictive tests currently available.
“Following our recent meeting with the staff of the Division of Psychiatry Products of the FDA we are accelerating our development plans for vilazodone and a companion biomarker test,” commented Dr Reed. “We believe this program has the potential to revolutionize the treatment of depression.”
The trial will enroll approximately 400 adult patients diagnosed with major depressive disorder at eight US centers.