Ireland-based Alkermes has started a Phase I clinical trial of its proprietary, oral, small-molecule drug candidate, ALKS 7106, for pain treatment.
Around 80 healthy, male adults will be enrolled in the randomised, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of ALKS 7106, which represents a new class of analgesic agents being developed at the company.
ALKS 7106 is a potent opioid modulator designed to treat pain with intrinsically low potential for abuse and overdose death.
Potential attributes of ALKS 7106 derive from its intrinsic mechanism of action in the brain rather than through the use of abuse-deterrent technologies or formulations.
Alkermes chief medical officer Dr Elliot Ehrich said: "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.
"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."
Results from the single-ascending-dose, multi-cohort, four-week Phase I trial are scheduled to be reported in the first half of 2015.
ALKS 7106 is seen to be highly potent in preclinical models, with similar efficacy to morphine at a 30-fold lower dose, and was well tolerated at doses far in excess of those required for analgesic action.
Additional preclinical data for the drug candidate showed a ceiling effect on neurotransmitter release over a broad concentration range, suggesting low potential for abuse and overdose death.