SamscaTreatment for Hyponatremia
Update: Samsca Now FDA Approved - May 19, 2009
FDA Advisory Committee Recommends Approval of Tolvaptan
U.S. Food and Drug Administration Advisory Committee Recommends Approval of Tolvaptan, an Investigational Treatment for Hyponatremia
PRINCETON, N.J., June 25, 2008 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) Advisory Committee on Cardiovascular and Renal Drugs voted to recommend the approval of tolvaptan, Otsuka Pharmaceutical Development & Commercialization, Inc.'s (OPDC) investigational treatment for patients with hyponatremia.
"Otsuka is pleased that the FDA Advisory Committee supports the potential approval of tolvaptan, an investigational selective V2-vasopressin receptor antagonist," said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer of OPDC. "We believe tolvaptan, if approved by the FDA, has the potential to be an important treatment option for people with hyponatremia."
Hyponatremia, characterized by low concentrations of sodium in the blood, is a known predictor of mortality in patients with serious underlying illnesses.(i) Sodium is an important electrolyte that plays a role in blood pressure maintenance, muscle movement, and fluid regulation in and around cells.(ii) Approximately 3.2 million to 6.1 million people in the U.S. suffer from hyponatremia annually.(iii)
Tolvaptan is an investigational selective antagonist of the vasopressin V2 receptor, which is located predominantly in the kidney and plays a role in the regulation of fluid retention in the body. Vasopressin V2 antagonists work by selectively blocking the V2 receptor. This mechanism of action hinders water reabsorption and results in increased free water excretion (aquaresis), which is characterized by increased urine volume with no increase in urinary electrolyte excretion.
OPDC was established in 2007 by Otsuka America, Inc. (OAI). OPDC is wholly owned by OAI, which is the holding company for Otsuka Pharmaceutical Co., Ltd. (OPC) interests in the U.S. OAI is wholly owned by OPC.
About Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization (OPDC) is involved in conducting all phases of clinical research and development of innovative healthcare products to address unmet medical needs. OPDC is well established in the scientific community as a globally focused organization that plays a leadership role in the research and development of Otsuka's ethical healthcare products. The Company is dedicated to the improvement of the quality of human life and health of patients around the world with a strong commitment to research and development in the areas of cardiovascular, neuroscience, renal and respiratory diseases, as well as cancer and ophthalmic disorders. The Company is part of the Otsuka Pharmaceutical Group, which is comprised of 104 companies and approximately 33,000 people around the world. Otsuka and its consolidated subsidiaries earned 928.4 billion Japanese yen in consolidated annual revenues in fiscal 2007. For additional information, please visit www.otsuka-us.com.
(i) Schrier RW, Gheorghiade M, Gross P, et al. Results from the SALT 1 and 2 Trials. Multicenter, Randomized, Placebo-Controlled Trials in Patients with Euvolemic and Hypervolemic Hyponatremia. Presented at American Heart Association's Scientific Sessions in November 2006.
(ii) The Mayo Clinic. Accessed at http://www.mayoclinic.com/print/hyponatremia/DS00974/METHOD=print&DSECTION=all on April 30, 2008.
(iii) Boscoe A, Paramore C, Verbalis JG. Cost of Illness of Hyponatremia in the United States. Accessed at http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1525202 on April 30, 2008.
CONTACT: Debra Kaufmann, Otsuka America Pharmaceutical, Inc., +1-240-683-3568, , or Miko Neri, Otsuka AmericaPharmaceutical, Inc., +1-240-683-3071, email@example.com firstname.lastname@example.org
Web site: http://www.otsuka-us.com/
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Posted: June 2008
- FDA Approves Samsca (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia - May 22, 2009
- New Drug Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatremia, Accepted by the U.S. Food and Drug Administration - December 21, 2007