Endocrine Abstracts

Background: Octreotide is the most widely used somatostatin analogue; however, the LAR formulation must be reconstituted prior to intramuscular injection. This Phase I study compared the pharmacokinetics and pharmacodynamics of octreotide Fluid Crystal (FC), a ready-to-use depot formulation for s.c. administration, vs octreotide LAR.Methods: After a single dose of octreotide s.c. 200 μg, healthy adult male/female volunteers were randomized 1 week la...

Background: Pasireotide is available in twice-daily subcutaneous (sc) and long-acting intramuscular (im) formulations. Pasireotide sc depot is an investigational extended-release sc formulation designed for improved handling and administration. Results are reported from a Phase I dose-escalating study.Methods: All subjects received a single dose of pasireotide sc (600 μg) and were randomized 12:2:2 to pasireotide sc depot as a single upper-thigh inj...

Background: Somatostatin receptor ligands (SRLs) are first-line standard-of-care therapies for gastroenteropancreatic neuroendocrine tumours (GEP-NETs), showing efficacy in tumour and symptom control with an established safety profile. However, disease progression may occur despite standard-dose SRL treatment, requiring more aggressive and toxic treatments. Retrospective/non-randomized data suggest higher-dose SRLs may benefit patients with GEP-NETs who do not respond to stand...

Background: Octreotide s.c. depot is a novel, ready-to-use formulation administered via a thin needle, which may allow self-administration. In a phase 1 study in healthy volunteers, octreotide s.c. depot provided greater bioavailability with faster onset and greater IGF1 suppression than long-acting octreotide. Here, we present data from a phase 2 study evaluating pharmacokinetics (PK), efficacy, safety, and tolerability of octreotide s.c. depot in patients with acromegaly and...

Acknowledgements: This study was funded by Camurus AB. Medical writing support was provided by Costello Medical and funded by Camurus AB.Background: Somatostatin receptor ligands (SRLs) are first-line standard of care therapies for gastroenteropancreatic neuroendocrine tumors (GEP-NET), showing efficacy in tumor/symptom control with an established safety profile. However, disease progression usually occurs despite standard-dose SRL treatment, requiring m...