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Hyperion Therapeutics' RAVICTI(TM) (glycerol Phenylbutyrate) Liquid Receives FDA Approval For Treatment Of Urea Cycle Disorders

"We believe the RAVICTI development program has brought not only a promising new drug to the UCD community, but also a much deeper understanding of UCD treatment," said Dr. Bruce F. Scharschmidt, M.D., Hyperion's chief medical officer and senior vice president. "The post-marketing studies and registry represent additional opportunities to expand our knowledge in areas that are important to the community, particularly in very young children, a population in which few systematic studies have been done."

Hyperion intends to commercially launch RAVICTI by the end of April. As part of the commercialization of RAVICTI, Hyperion today announced the launch of a dedicated call center, Hyperion UCD Support Services, which will serve as an integrated resource for patients and their physicians in the areas of RAVICTI prescription intake, reimbursement adjudication, patient financial support, and ongoing compliance support. Together with distribution via two specialty pharmacies, the Company believes that its UCD Support Services program will provide better support to UCD patients, their families and their physicians and help them better manage their disease.  

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 urea cycle disorders (UCDs) 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 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 hyperammonemia.
  • 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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