By GlobeNewswire, February 28, 2013, 04:05:00 PM EDT
SOUTH SAN FRANCISCO, Calif., Feb. 28, 2013 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that RAVICTI™ (glycerol phenylbutyrate) Liquid is now available for shipment to patients. RAVICTI was approved by the U.S. Food and Drug Administration (FDA) on February 1, 2013, for use as a nitrogen-binding agent for the chronic management of adult and pediatric patients two years of age or older with urea cycle disorders (UCD), who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. The new drug is being distributed exclusively via select specialty pharmacies. To prescribe RAVICTI or for more information regarding the medication, reimbursement, and other patient support services, individuals may call 1-855-UCD-SUPT (1-855-823-7878) or visit www.ravicti.com.
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.
Pancreatic insufficiency or intestinal malabsorption may result in reduced or absent digestion of RAVICTI and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely in these patients.
Most common adverse reactions in 10% or more of patients are: diarrhea, flatulence, headache, nausea, vomiting, fatigue, decreased appetite, HA, dizziness, headache, upper abdominal (stomach) pain and rash.
Corticosteroids, valproic acid, or haloperidol may increase plasma ammonia levels; monitor ammonia levels closely when used concomitantly with RAVICTI. Probenecid may affect renal excretion of metabolites of RAVICTI including PAGN and PAA.
The use of RAVICTI in pregnant women may cause fetal harm. Breastfeeding is not recommended during RAVICTI treatment.
Please see full Prescribing Information for RAVICTI at www.hyperiontx.com.
About Hyperion Therapeutics
Hyperion Therapeutics, Inc. is a commercial stage biopharmaceutical company committed to developing and delivering life-changing treatments for orphan diseases and hepatology. For more information, please visit www.hyperiontx.com
To the extent that statements contained in this press release are not descriptions of historical facts regarding Hyperion, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations regarding the timing of to establishing comprehensive payor coverage. Forward-looking statements in this release involve substantial risks and uncertainties that could cause future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks related to: the ability to comply with requirements established by the FDA, including post-marketing requirements and label restrictions; the success and timing of commercialization efforts of Ravicti; the uncertain clinical development process; the satisfaction of the FDA with preclinical data, including carcinogenicity data; the fact that the patient population suffering from UCD is small and has not been established with precision; the ability to obtain adequate clinical supplies of Ravicti; and the ability to raise sufficient capital to complete the development of and commercialize Ravicti in UCD. Hyperion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see the section entitled "Risk Factors" in Hyperion's Annual Report on Form 10-K/A for the year ended December 31, 2012, and in subsequent filings with the Securities and Exchange Commission.
CONTACT: Shari Annes, Investor Relations
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Source: Hyperion Therapeutics, Inc.