Clinical-stage biopharmaceutical firm Pain Therapeutics has presented top-line results of a FDA category 3 human abuse potential study with Remoxy extended-release capsules CII.
Remoxy extended-release capsules CII is the firm’s lead drug candidate, which is specifically designed as twice-a-day formulation of oral oxycodone to prevent certain common methods of drug tampering and misuse.
According to the company, the study showed with statistical significance (p < 0.0001) that both intact and chewed Remoxy were less liked than immediate-release oxycodone on the two primary endpoints drug liking and drug high.
The trial has been conducted in non-dependent and recreational opioid users, as per the FDA guide lines.
Pain Therapeutics chief medical officer Dr Nadav Friedmann said: "We believe today’s results demonstrate abuse-deterrent properties of the Remoxy formulation against a common, and often lethal, form of oral drug abuse."
The study has been randomised, double-blind, placebo and active controlled, using a four-way crossover design in healthy, non-dependent recreational opioid users.
With an average age of 27 years, around 60 subjects completed this study, where the primary objective was to measure the abuse potential of chewed and intact 40mg Remoxy compared to 40mg immediate-release (IR) oxycodone when taken orally.
The subjects of the study have been instructed to chew Remoxy capsules vigorously for up to five minutes, but failed to do in the light of Remoxy’s high viscosity, texture or taste.
The firm noted that pharmacodynamic measures of the primary endpoints drug liking and drug high included use of a standard 0-100 point visual analogue scale (VAS) in the initial two hours post-dose (AUC02h), as recommended by FDA to assess a formulation’s abuse potential.