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invivodata Captures Symptom Relief Data in Endometriosis Trial
Date:9/25/2008

Neurocrine Biosciences Demonstrates Rapid and Significant Pain Reduction with Elagolix

PITTSBURGH, Sept. 25 /PRNewswire/ -- invivodata inc., the industry leader in electronic patient reported outcomes (ePRO) solutions and services for global clinical research, today announced that its DiaryPRO(R) field-based ePRO system was used to capture important secondary efficacy endpoint data in Neurocrine Biosciences' (Nasdaq: NBIX) PETAL study, a Phase II clinical trial of its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

Over 250 patients used invivodata's electronic diary twice daily to record the frequency and severity of endometriosis symptoms before, during, and after six months of treatment, using several different scales to measure dysmenorrhea and pelvic pain. Data captured on DiaryPRO helped Neurocrine demonstrate a clinically meaningful and statistically significant reduction in endometriosis pain from baseline among patients treated with elagolix.

"When conducting a clinical trial of this importance and magnitude, it's critical to choose a vendor that is knowledgeable about clinical development and easy to work with," said Chris O'Brien, MD, Chief Medical Officer at Neurocrine Biosciences. "invivodata's process for designing and implementing ePRO was comprehensive and straightforward, and easily fit within our clinical development timeline."

"The PETAL study represents an important step forward in Neurocrine's ongoing efforts to bring relief to patients suffering from endometriosis," said Doug Engfer, invivodata president and CEO. "We are thrilled to continue working with Neurocrine as they explore the full therapeuti
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SOURCE invivodata inc.
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