Health Canada issues notice of compliance for OCPI's SAMSCA to treat hyponatremia

Otsuka Canada Pharmaceutical Inc. (OCPI) announced today that Health Canada has issued a notice of compliance for SAMSCA^® (tolvaptan), the first medicine approved in Canada for the treatment of hyponatremia. SAMSCA is expected to become available to treat patients in Canada in September of this year.

Hyponatremia is a condition in which a patient's blood level of sodium is abnormally low. When the sodium level in fluids outside cells drops, water moves into the cells, causing the cells to swell. In the most severe cases, this can cause symptoms including mental confusion, reduced consciousness or coma, seizures and even death. Hyponatremia is the most common electrolyte disorder, and can be an important predictor of mortality in hospitalized patients.

SAMSCA is an oral, selective vasopressin V₂-receptor antagonist, which was discovered and developed by Otsuka Pharmaceutical Co., Ltd. It is indicated to treat patients with clinically important, non-hypovolemic hyponatremia, e.g. serum sodium less than 130 mEq/L, or symptomatic hyponatremia.

Patients with this type of hyponatremia may include those with congestive heart failure, cirrhosis, and the syndrome of inappropriate anti-diuretic hormone (SIADH), which often affects patients with small-cell lung cancer. 

"Hyponatremia can represent a severe and dangerous complication for patients already dealing with significant underlying illnesses, and it is a condition that is sometimes difficult to diagnose and treat effectively," said Dr. Daniel Bichet, Nephrologist and Researcher at the Centre de recherche de l'Hôpital du Sacré-Cœur de Montréal and Professor at the Medicine and Physiology Departments of Université de Montréal. "For physicians who treat patients with clinically significant hyponatremia, SAMSCA is a breakthrough advance in therapy. In clinical trials and in clinical use in other countries, it has proven to be effective and have a positive safety profile. It is the first medicine approved in Canada specifically to treat hyponatremia."

"The Canadian approval of SAMSCA is an important milestone for patients and physicians, and for our company," said Masaru Taguchi, General Manager of Otsuka Canada Pharmaceutical, Inc. "SAMSCA meets a significant unmet medical need, and will provide treating physicians with a valuable new tool to treat hyponatremia. For Otsuka, the launch of our third medicine in this country is a significant step forward in the growth of our Canadian presence, and our contribution to the Canadian health care system."

Source: OTSUKA CANADA PHARMACEUTICAL INC.