"Every time I come across a technically challenging problem, I know I can count on PharmaDirections to help me find a solution."
Klara Dickinson, Senior VP, Regulatory Affairs and Compliance
Cary, NC (PRWEB) February 27, 2013
PharmaDirections congratulates Hyperion Therapeutics on achieving a NDA approval for their RAVICTI™ (glycerol phenylbutyrate) Liquid for Treatment of Urea Cycle Disorders. PharmaDirections is proud to have been involved as a pharmaceutical development partner and to have helped in the development of Hyperion's first product to complete full clinical development.
Hyperion has achieved a major milestone for adult and pediatric patients ≥2 years of age with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of UCD. In clinical studies, RAVICTI kept ammonia at safe levels throughout the day and night and over the long-term (1 year).
PharmaDirections participated in this important program by providing CMC and PK support over the past four years. They were responsible for overseeing the development of the API manufacturing process. They used their process chemistry expertise to review the synthetic scheme and to propose improvements for API synthesis development and optimization that led to improvements in the manufacturing process. Their scientific experts led efforts in formulation development, bioanalytical method development and pharmacokinetic analyses. Their regulatory affairs experts helped in the NDA preparation process by authoring and completing specific areas of the CMC section. PharmaDirections was proud to be a part of this team.
PharmaDirections is a pharmaceutical consulting and project management company with special expertise in preclinical development, Chemistry and Manufacturing Controls, and regulatory affairs. They design and direct outsourced R&D programs for biotech and pharmaceutical firms. They allow virtual biotech firms to achieve their development milestones on time and on budget because of PharmaDirections' long term relationships with CRO and CMOs, and the extensive scientific expertise.
For more information please visit http://www.PharmaDirections.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 http://www.hyperiontx.com.