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news.Cara Therapeutics has initiated a human abuse liability (HAL) trial of an intravenous formulation of its peripherally-selective kappa opioid agonist, CR845. The company expects to report top-line data from this trial in the fourth quarter of 2014.
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"The initiation of this human abuse liability study is a key milestone in the development path for CR845," said Robert Medve, M.D., Chief Medical Officer of Cara Therapeutics.
"Prescription opioid abuse is a worsening public health crisis. This trial will assess CR845’s lower abuse potential, relative to pentazocine, a Schedule IV analgesic. We believe that this HAL study for CR845, if successful, combined with the analgesic efficacy already demonstrated in two Phase 2 surgical models, will underscore the potential for CR845 to provide a significant, highly differentiated advancement in pain care."
The HAL study is a double-blind, randomized, active- and placebo-controlled four-way crossover trial that will evaluate the abuse potential of I.V.
CR845 in non-dependent, recreational polydrug users with lifetime and recent hallucinogenic drug use. The primary objective of the trial is to measure the relative abuse potential of both a therapeutic and supratherapeutic dose of CR845, compared to an intravenous dose of pentazocine.
Pentazocine is a mixed-action kappa and mu opioid receptor agonist used clinically in the treatment of moderate-to-severe pain and is classified by the Drug Enforcement Agency as a Schedule IV drug, indicative of reduced abuse liability compared to most other narcotics.