FDA Approves New Somatuline Depot Syringe
New features to ease injection administration.
The FDA has approved a newly designed syringe for the administration of Somatuline Depot (lanreotide, Ipsen Biopharmaceuticals).
The new syringe has been redesigned with larger flanges to make administering the injection easier for healthcare professionals, a needle shield removal system, and more stable plunger and thermoform tray with recessed areas to prevent accidental plunger depression.
This new system was tested in five separate, but complementary studies in partnership with patients, caregivers, nurses and other healthcare providers to better understand the use of the existing syringe.
“We consistently look for opportunities to respond to the needs of the communities we serve, and this approval would not have been possible without the direct involvement of nurses and the patients with GEP-NETs and acromegaly whom they treat,” said Bradley Bailey, SVP, and Franchise Head Oncology/Endocrinology Business Unit at Ipsen, in a statement. “We listened and collaborated to enhance the existing pre-filled 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.”
Somatuline Depot is a somatostatin indicated for the long-term treatment of acromegalic patients who have had an inadequate response to, or cannot be treated with, surgery and/or radiotherapy; adult patients with unresecetable, well- or moderately-differentiated, locally advanced or metastatic gastronenteropancreatic neuroendocrine tumors to improve progression-free survival, and adults with carcinoid syndrome.
Somatuline Depot is contraindicated for patients that have exhibited a hypersensitivity to lanreotide.
