- Relmada Therapeutics (NASDAQ:RLMD) soars 55% premarket after announcing top-line results of the human abuse potential (HAP) study with REL-1017, the company's lead candidate in Phase 3 development for the treatment major depressive disorder (MDD).
- Top-line results showed that all three doses of REL-1017 (25 mg, 75 mg and 150 mg) tested in recreational opioid users, demonstrated a highly statistically significant difference vs. the active control drug, oxycodone 40 mg.
- The study's primary endpoint was a measure of "likability" with the subjects rating the maximum effect (or Emax) for Drug Liking "at the moment", using a 1=100 bipolar rating scale (known as a visual analog scale or VAS).
- Mean Emax for Drug Liking for REL-1017 at 25, 75 and 150 mg dose 53.0, 58.2, 64.9, respectively compared to 51.7 for placebo and 85.0 for Oxycodone 40 mg.
- "These results, along with previously published literature, confirm the lack of opioid effects of REL-1017. We look forward to the continued clinical development of REL-1017 as a novel, safe and rapidly effective treatment for MDD," said Sergio Traversa, CEO.
- Prior preclinical and clinical findings have indicated that the dextro-isomer REL-1017 lacks the addiction liability and respiratory depressant effects of its parent molecule.