The Food and Drug Administration (FDA) has approved a new prefilled syringe for Somatuline Depot (lanreotide; Ipsen) to make it easier for healthcare providers to administer the injection.
The redesigned syringe includes a needle shield removal system and more stable plunger and thermoform tray with recessed areas designed to help prevent accidental plunger depression; the built-in safety system remains unchanged. The new device also has larger flanges to make it easier to grip and administer the injection.
“We listened and collaborated to enhance the existing prefilled syringe, making it sturdier for healthcare providers when administering treatment, with the intention of improving the injection process. We look forward to bringing this innovation to healthcare providers for their patients soon,” said Bradley Bailey, SVP, and Franchise Head Oncology/Endocrinology Business Unit at Ipsen.
The indications for Somatuline Depot will remain the same and include the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; treatment of adults with carcinoid syndrome to reduces the frequency of short-acting somatostatin analogue rescue therapy; and the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
The redesigned syringe is expected to be distributed in the third quarter of 2019. The product is currently available in 60mg/0.2mL, 90mg/0.3mL, and 120mg/0.5mL strengths in prefilled syringes intended for deep subcutaneous injection.
For more information visit ipsen.com.