Alkermes plc announced the initiation of a Phase 1 clinical study of ALKS 7106, a proprietary, novel, oral, small-molecule drug candidate for the treatment of pain. The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 in approximately 80 healthy, male adults. ALKS 7106 represents a new class of analgesic agents in development at Alkermes: potent opioid modulators designed for the treatment of pain with intrinsically low potential for abuse and overdose death– two liabilities associated with opioid analgesics. ALKS 7106’s potential attributes derive from its intrinsic mechanism of action in the brain rather than through the use of abuse-deterrent technologies or formulations.
“Pain relievers are some of the most prescribed medicines in America, and there is a significant need for new opioid treatment options for pain that can provide analgesic effect with lower abuse potential and risk of overdose, compared to conventional opioid pain medications,” said Elliot Ehrich, chief medical officer of Alkermes. “Based on preclinical studies, ALKS 7106 appears to have intrinsic properties that may address these serious risks while maintaining analgesic effect, and we look forward to determining whether these findings are also observed in the clinic.”
This Phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose, multi-cohort, four-week study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 administered orally in approximately 80 healthy, male adults. Results from this phase 1 study are expected in the first half of 2015.
Date: August 26, 2014