FDA Approves Somatuline Depot to Treat Carcinoid Syndrome
The Food and Drug Administration (FDA) has approved Somatuline Depot (lanreotide; Ipsen) for the treatment of carcinoid syndrome, to reduce the frequency of short-acting somatostatin analog rescue therapy.
The approval was based on data from a randomized, double-blind, placebo-controlled trial (Study 4). The 16-week study (n=115) enrolled patients with histopathologically-confirmed neuroendocrine tumors and a history of carcinoid syndrome who were treatment-naive or stable on another somatostatin analog. Patients were randomized to Somatuline Depot 120mg or placebo.
The use of rescue therapy and the severity and frequency of diarrhea and flushing symptoms were recorded daily. The primary efficacy outcome was the percentage of days in which patients given ≥1 injection of rescue medication for symptom control. The data showed patients treated with Somatuline Depot had 15% fewer days on rescue medication vs. patients in the placebo arm (34% vs. 49%; P=0.02). Also, Somatuline-treated patients had lower average daily frequencies of diarrhea and flushing events vs. placebo but these were not statistically significant.
Somatuline Depot, a somatostatin analog, is currently approved for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an potion. Also, it is indicated to improve progression-free survival (PFS) in patient with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Its mechanism of action is similar to that of natural somatostatin.
Somatuline Depot is available 60mg/0.2mL, 90mg/0.3mL, and 120m/g0.5mL strengths in prefilled syringes intended for deep subcutaneous injection.
For more information call (85) 463-5127 or visit SomatulineDepot.com.