Novartis Submits NDA for Sandostatin LAR

Novartis Pharmaceuticals Corporation (East Hanover, NJ) has submitted a new drug application to the U.S. Food and Drug Administration for Sandostatin LAR, a long-acting release formulation of Sandostatin (octreotide acetate).

Sandostatin is currently used to treat certain patients with acromegaly; to control symptoms such as severe diarrhea and flushing in patients with metastatic carcinoid tumors; and to control the profuse, watery diarrhea associated with vasoactive intestinal peptide-secreting tumors (VIPomas). Novartis has requested clearance from the FDA to market Sandostatin LAR for the same indications. If approved for marketing, the new, long-acting formulation will be administered via a single, monthly intramuscular injection.

Sandostatin mimics the action of the naturally-occurring hormone somatostatin, which helps regulate a number of important functions in the body. Acromegaly, a chronically disfiguring and debilitating disorder characterized by physical changes to the face, hands and feet, results from excessive secretion of growth hormone, which is generally caused by a pituitary tumor. Carcinoid tumors are often clinically silent, but some patients develop carcinoid syndrome, characterized by episodic or permanent flushing, diarrhea, abdominal pain and valvular heart disease. VIPomas are neuroendocrine tumors usually found in the pancreas. The tumors secrete VIP, a peptide, which modulates intestinal water and electrolyte flow.

Novartis Pharmaceuticals Corporation, an affiliate of the Novartis Group (Basel, Switzerland), researches, develops, manufacturers and markets prescription drugs used to treat central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis.

Edited by Beth Brindle

For more information: Gloria C. Stone, Novartis Pharmaceuticals Corporation. Tel: 973-781-5587.