Amryt announces positive long-term safety and efficacy data from global open-label extension (OLE) of MPOWERED phase 3 trial of oral octreotide (Mycapssa®) in management of acromegaly in patients

In OLE (n=60), patients maintained their long-term biochemical response with 94%, 90% & 93% maintaining response at year 1, 2 & 3, respectively. Long-term safety profile was consistent with that observed in prior studies & IGF-1 levels were stably maintained within normal limits.

SPS commentary:

The phase 3 MPOWERED non-inferiority clinical trial compared oral octreotide capsules to long-acting injectable somatostatin receptor ligands for maintenance of biochemical response in patients with acromegaly. It was designed to support the marketing authorization application to the EMA which is currently under evaluation. It is already approved in US for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

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