SAN DIEGO, Dec. 15, 2010 /PRNewswire/ -- Ocera Therapeutics, Inc. announced today that it has completed two studies evaluating the safety and pharmacokinetics of OCR-002 (ornithine phenylacetate) which includes healthy volunteers and patients with liver cirrhosis. OCR-002 recently received Orphan Drug status and Fast Track designation by the United States Food and Drug Administration for the treatment of hyperammonemia (excessive ammonia levels) and resultant Hepatic encephalopathy. Patients with liver failure and decompensated cirrhosis may present with confusion and coma, a frequent complication known as acute hepatic encephalopathy (AHE) and an indicator of poor long-term survival.
Orphan Drug designation applies to a compound being developed to treat a rare medical condition. It offers a number of potential incentives, which may include a seven-year period of U.S. marketing exclusivity from the date of marketing authorization, funding for clinical studies, study design assistance, waiver of FDA user fees, and tax credits for clinical research. The Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs often qualify for priority review, thereby expediting the FDA review process.
"Unlike current treatments that target the production of ammonia in the intestinal tract, OCR-002 directly reduces toxic levels of ammonia in the blood that lead to severe neurologic complications including coma. AHE is associated with substantial morbidity and mortality, and OCR-002 has the potential to be a novel therapeutic option for these patients," stated Dr. Laurent Fischer, CEO of Ocera Therapeutics. "Our receipt of Orphan Drug status and Fast Track designation for OCR-002 reinforce the clinical unmet need in AHE, and demonstrate the imp
|SOURCE Ocera Therapeutics, Inc.|
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