Amryt Announces Positive Long-Term Safety and Efficacy Data for Mycapssa® (oral octreotide) from the 2nd Year of OPTIMAL Open Label Extension Study in Acromegaly Patients
~ Acromegaly patients were exposed to Mycapssa® during the OPTIMAL Phase 3 Trial, including its open label extension (OLE), for a maximum treatment duration of 3.2 years ~ Study demonstrated that 100% of evaluable patients who entered the 2nd year OLE phase of the study as responders - insulin-like growth factor 1 (IGF-1) within normal limits - maintained their long-term biochemical response at the end of the study ~ IGF-1 levels were stably maintained within normal limits at the end of the OLE period (mean IGF-1 levels at baseline and at the end of the OLE were 0.92 and 0.84 respectively) ~ Growth hormone (GH) levels also improved at the end of the OLE period (mean GH levels at baseline and at the end of the OLE were 0.79 and 0.45 respectively) ~ Long-term safety profile of Mycapssa® during the OLE was consistent with that observed in prior studies
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