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Hyperion Therapeutics Receives Orphan Drug Exclusivity From FDA

SOUTH SAN FRANCISCO, Calif., May 2, 2013 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the U.S. Food and Drug Administration (FDA) yesterday notified the company that RAVICTI™ (glycerol phenylbutyrate) Liquid has qualified for orphan drug exclusivity. The orphan exclusivity is for seven years from the date of the approval on February 1, 2013.

According to Donald J. Santel, president and chief executive officer, "Orphan drug exclusivity further strengthens the protections for RAVICTI. Additionally, as we recently announced, we were issued a patent that relates to use of RAVICTI with optimal measurement timing and target levels for blood ammonia in urea cycle disorder (UCD) patients. It has a term that expires in March 2032 and is now listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book."

RAVICTI Indications, Usage and Safety Information

RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥ two years of age with UCD that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, protein-free calorie supplements).

Limitations of Use:

  • RAVICTI is not indicated for the treatment of acute hyperammonemia (HA) in patients with UCD because more rapidly acting interventions are essential to reduce plasma ammonia levels.
  • The safety and efficacy of RAVICTI for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established.

RAVICTI is Contraindicated in Patients:

  • Less than two months of age. Children less than two months of age may have immature pancreatic exocrine function which could impair hydrolysis of RAVICTI, leading to impaired absorption of phenylbutyrate and HA.
  • With known hypersensitivity to phenylbutyrate. Signs of hypersensitivity include wheezing, shortness of breath, coughing, low blood pressure, flushing, nausea and rash.

The major metabolite of RAVICTI, PAA, is associated with neurotoxicity at levels ≥ 500 μg/mL. If symptoms of vomiting, nausea, headache, drowsiness, or confusion are present in the absence of high ammonia or other intercurrent illnesses, reduce the RAVICTI dosage.

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