Alkermes
plc introduced topline results through a phase 2b dose-ranging clinical study
of ALKS 37 within the treatment of opioid-induced constipation. The
multicenter, randomized, double-blind, placebo-controlled, repeat-dose study
was created to determine the protection, tolerability, pharmacokinetic profile
and performance of ALKS 37 in about 150 affected individuals.
ALKS
37 ended up being generally good tolerated in any respect dose levels, and
though subjects taking ALKS 37 demonstrated a rise in bowel movements when
compared with baseline, the product profile do not satisfy our pre-specified
criteria for promoting into phase 3 clinical trials. Based upon this analysis,
Alkermes decided not to advance ALKS 37 and can consider out-licensing chances.
"We
had established the product profile we wanted to observe with the intention to
continue to advance ALKS 37 into phase 3 clinical studies. According to the
results of this study, we are going to focus our future clinical development
efforts on our other development programs, which includes ALKS 9070 for
schizophrenia and ALKS 5461 for major depressive conditions," said Dr.
Elliot Ehrich. "We are going to continue to keep a disciplined method of
R&D and focus our assets on clinical aspirants that in fact show the
foremost promise."
The
second phase 2b study of ALKS 37 for the treatment of opioid-induced
constipation is winding up, and no excess clinical studies for ALKS 37 are
planned.
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