Sandostatin LAR Depot Approved for Carcinoid Syndrome

EAST HANOVER, NJ—Novartis Pharmaceuticals has received FDA approval to market Sandostatin LAR Depot (octreotide acetate for injectable suspension) for the treatment of acromegaly and to control the symptoms of metastatic carcinoid tumors and the profuse watery diarrhea associated with vasoactive intestinal peptide secreting tumors (VIPomas).

In all indications, it is recommended that patients respond to and tolerate initial treatment with subcutaneous Sandostatin (octreotide acetate injection).

Sandostatin imitates the action of somatostatin, an inhibitor of growth hormone and other substances, including insulin growth factor (IGF-1). The depot agent uses a microsphere delivery system to provide slow release of the drug.

Carcinoid syndrome occurs when a carcinoid tumor produces excess hormones, leading to symptoms such as severe diarrhea, wheezing attacks, and flushing of the face. VIPomas, neuroendocrine tumors usually found in the pancreas, secrete VIP, a peptide that modulates intestinal water and electrolyte flow.

The indication for carcinoid syndrome was based on one 6-month trial comparing intragluteal injections of the depot agent (10, 20, or 30 mg every 28 days) with SC injections of Sandostatin three times daily. The results showed that the long-acting agent effectively controlled diarrhea and flushing in most patients.