Amryt's Mycapssa Gets Orphan Drug Status For Treatment Of Carcinoid Syndrome

(RTTNews) - Amryt (AMYT) on Thursday said the Food and Drug Administration has granted Orphan Drug Designation to its Mycapssa for the treatment of carcinoid syndrome.

Carcinoid syndrome is a set of symptoms associated with neuroendocrine tumors (NETs).

Mycapssa (oral octreotide) is approved by the FDA for long-term maintenance treatment in acromegaly patients who have responded to and tolerated injectable treatment with octreotide or lanreotide.

Pharmacokinetic studies with Mycapssa showed dose linearity from 20mg to 80mg, hence support dosing requirements for the planned Phase 3 study in patients with carcinoid syndrome, planned to be initiated early in 2023, Amryt said.