Synergy Pharma To Begin Phase 2 Trial Of SP-333 For Opioid-Induced Constipation

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP) said it intends to move forward this quarter with SP-333, its proprietary next-generation guanylate cyclase-C or GC-C agonist, into a phase 2 trial for opioid-induced constipation or OIC treatment.

The phase 2 study is designed as a dose-ranging study to evaluate a 4-week regimen of SP-333, a once daily oral treatment, in adult patients taking opioid analgesics for chronic, non-cancer pain for at least 3 months. The only oral drug currently FDA approved to treat OIC in patients with chronic, non-cancer pain requires multiple daily dosing and it is not effective against methadone-related OIC.

The company's President and Chief Executive stated, "We recognize a significant market opportunity for new OIC drug candidates and believe SP-333 has excellent potential to address the unmet medical needs of these patients. We look forward to evaluating the potential role of SP-333 for OIC as part of our continuing commitment to deliver value to our shareholders and improve patient care."

Pre-clinical data on SP-333 in an animal model of OIC would be featured in a poster presentation at the American College of Gastroenterology 2013 Annual Scientific Meeting being held October 11-16 in San Diego, California.