The primary endpoint was met:58% of the patients on octreotide capsules maintained their IGF-1 response compared to 19% of the patients on placebo (p = 0.008).
Mycapssa® Secondary Efficacy Data:
- 78% of patients treated with octreotide capsules maintained their growth hormone (GH) levels below 2.5 ng/mL at the end of the core study vs. 30% of patients treated with placebo (p = 0.001)
- Median time to loss of response (IGF-1 >1.0 × ULN) was not reached (>36 weeks) for patients treated with octreotide capsules vs. 16 weeks for patients treated with placebo (p <0.001)
- Median time to loss of response (IGF-1 ≥ 1.3 × ULN) was not reached (>36 weeks) for patients treated with octreotide capsules vs. 16 weeks for patients treated with placebo (p <0.001)
- 25% of patients treated with octreotide capsules required rescue medication with injectable SSAs (octreotide LAR or lanreotide depot) anytime throughout the study vs. 68% of patients treated with placebo (p =0.003)
