Date: 2015-02-24
Type of information: Results
phase: 1
Announcement: results
Company: Alkermes (Ireland)
Product: ALKS 7106
Action
mechanism: ALKS 7106 belongs to 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.
Disease: pain
Therapeutic area: CNS diseases
Country:
Trial details:
Latest
news: * On February 24, 2015, Alkermes announced topline results from a phase 1 clinical study of ALKS 7106, a new molecule intended for the treatment of pain. The randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability and pharmacokinetics of single escalating doses of ALKS 7106 in 64 healthy adults. Data from the study showed that ALKS 7106 did not meet the company's pre-specified criteria for advancing into phase 2 clinical trials. Based on this evaluation, Alkermes will not pursue further development of ALKS 7106. The company will continue its efforts in developing novel compounds for the treatment of pain with intrinsically low potential for overdose toxicity and abuse, and it will now concentrate its efforts on the development of back-up compounds. * On August 26, 2014, Alkermes 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. 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.
