To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Sandostatin For Symptoms Of Pituitary, Intestinal And Carcinoid Tumous URL: http://www.pslgroup.com/dg/C792A.htm Doctor's Guide November 30, 1998
EAST HANOVER, NJ -- Nov. 30, 1998 – The United States Food and Drug Administration has approved Novartis Pharmaceuticals Corp.'s Sandostatin Lar(R) Depot (octreotide acetate for injectable suspension) for the treatment of acromegaly, a chronically disfiguring and debilitating hormonal disorder that affects more than 19,000 Americans. Sandostatin Lar Depot also was cleared for marketing to control the symptoms, such as severe diarrhea and flushing, of metastatic carcinoid tumours and the profuse, watery diarrhea associated with vasoactive intestinal peptide secreting (VIPomas) tumours. In all indications, it is recommended that patients respond to and tolerate initial treatment with subcutaneous injections of Sandostatin(R) (octreotide acetate injection). Acromegaly is caused by the excessive secretion of growth hormone (GH), resulting from a tumour on the pituitary gland. Growth hormone is a key factor in body growth and organ development. Its hypersecretion can result in overgrowth of body parts and enlargement of various organs. The consequences of this can result in complications associated with increased morbidity and mortality. As a result, individuals with acromegaly have a mortality rate two to four times higher than that of the general population -- comparable to that of more prevalent diseases, such as diabetes and Parkinson's disease -- and, on average, die up to 10 years earlier than otherwise healthy individuals. Complications associated with acromegaly include cardiovascular disease; respiratory distress, such as upper airway obstructions; malignancies, such as colon cancer; and carbohydrate intolerance, which can lead to diabetes. "This new long-acting drug now allows us to offer our patients a once-a-month therapy," said Shlomo Melmed, M.D., senior vice president for academic affairs and professor and director of the Cedars-Sinai Research Institute, Los Angeles, CA. "One injection a month will allow effective biochemical control of the growth hormone hypersecretion, it will improve the clinical disorders associated with acromegaly and it will be convenient for the patient." Sandostatin Lar Depot works by imitating the action of somatostatin, a hormone found naturally in the body, which inhibits the release of growth hormone and other substances, including IGF-1 (insulin growth factor). Sandostatin Lar Depot helps reduce and normalise levels of IGF-1 and growth hormone (less than or equal to 2.5ng/mL). Utilising a microsphere delivery system, this new drug provides a slow release of octreotide acetate from the site of injection and offers long-lasting control over the course of a month. Diagnosis of acromegaly can often be missed for up to 10 years because signs and symptoms develop gradually and because people do not seek treatment for the physical manifestations. These physical manifestations include: coarsening of facial features, such as enlargement of tongue and wide spacing of teeth; enlargement of hands and feet, including thickened fingers, increased length and width of feet, thickening of heel pads and increased ring, glove and shoe size; and enlargement of internal organs, such as the heart, liver or kidney. Typically, however, people with acromegaly are more likely to seek treatment for symptoms such as fatigue and weakness, headaches, disruption of menstrual cycle, hypersomnolence (excessive sleeping) and joint pain, often in the knees, shoulders or back (usually due to osteoarthritis). Marketing clearance was based upon the results of three major clinical trials, which evaluated Sandostatin Lar Depot in patients who have responded to and tolerated subcutaneous injections of Sandostatin. Two trials examined 101 patients for up to 27 months. The third trial examined 151 patients for 12 months. Over the course of these trials, once-monthly injections of Sandostatin Lar Depot substantially reduced or normalised growth hormone and/or IGF-1 levels in the majority of patients. In addition, most patients showed an improvement in the symptoms associated with the disease. Found in many organs of the body, carcinoid tumours are neuroendocrine tumours that tend to grow slowly and are clinically silent. Some carcinoid tumours produce excess hormones, causing a state known as carcinoid syndrome, which is characterised by severe and debilitating diarrhea, asthma-like wheezing attacks and hot red flushing of the face. Carcinoid syndrome can severely impact a person's day-to-day life and, in and of itself, can be life-threatening. The severe diarrhea associated with the condition can consist of over 12 episodes per day and cause marked debilitation with depletion of fluids, electrolytes and proteins. VIPomas are neuroendocrine tumours that are usually found in the pancreas. These tumours secrete VIP, a peptide, which modulates intestinal water and electrolyte flow. A debilitating manifestation of VIPomas is sudden, intense secretory diarrhea. The indication of Sandostatin Lar Depot for the treatment of carcinoid syndrome was based upon one six-month trial, which compared intragluteal (buttocks) injections of Sandostatin Lar Depot (10, 20 or 30 mg doses administered every 28 days) to three times a day (t.i.d.) subcutaneous injections of Sandostatin. These trials demonstrated that Sandostatin Lar Depot effectively controlled diarrhea and flushing in most patients with carcinoid syndrome. Sandostatin Lar Depot is administered under the supervision of a healthcare professional via a single, intragluteal injection every four weeks. The recommended starting dose is 20 mg. For carcinoid and VIPoma patients, concomitant subcutaneous injections of Sandostatin should be administered for at least the first two weeks of Sandostatin Lar Depot therapy. In clinical studies of acromegaly, some patients experienced diarrhea, abdominal pain, gas, constipation, nausea, vomiting, pain at injection site, slow or irregular heart rate, and high or low blood sugar levels. In studies of carcinoid syndrome, some patients experienced nausea, abdominal pain, headache, dizziness, fatigue, gas, vomiting, pain at injection site and low blood sugar levels. In studies of both conditions, some patients developed gallstones, although few patients required treatment. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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