To evaluate Mirogabalin as a well-tolerated novel α2δ ligand with low abuse potential.
The HAP study was designed as 2 independent studies intended to evaluate the abuse potential of Mirogabalin versus a) placebo and Diazepam, and b) placebo and Pregabalin, in recreational drug users. Each study was divided into 2 parts: a qualification phase and an assessment phase. The study comparing Mirogabalin to Diazepam was conducted as a randomized, placebo and active-controlled crossover study involving 38 recreational polydrug users who had a history of CNS depressant use. In evaluating the abuse potential of Mirogabalin against Pregabalin, a single ascending dose study in 24 subjects was first conducted to evaluate 3 doses of Mirogabalin. The data from this study was then used to select the doses to be used in the abuse potential study with 56 participants, which had a similar design to the Diazepam study.
In both studies, the planned therapeutic dose of Mirogabalin did not have maximal Drug Liking scores different from the placebo. These scores were also found to be significantly less than therapeutic doses of Diazepam and Pregabalin. The overall incidence of adverse events of Mirogabalin was comparable to, or lower than the placebo in both studies.
The studies showed that a therapeutic dose of Mirogabalin is a safe and well-tolerated α2δ ligand with low potential for abuse in recreational polydrug users.