Full Press Release Details
We have recently initiated two separate
human abuse potential studies, REL-1017-120 and REL-1017-124, using 100 mg oral ketamine and 40 mg oral oxycodone as positive controls,
While the oxycodone study is advancing
as planned and is expected to generate top line data in the second quarter of 2021, the ketamine study, due to the suspected inadequacy
of the active control in the trial, 100 mg of ketamine delivered orally, has been terminated early.
No safety signal and no psychotomimetic
symptoms (delusions and/or delirium, hallucinations) were observed in any of the 5 arms of the REL-1017-120 study, including
the three tested dose levels of Rel-1017.
As part of data monitoring for the REL-1017-120
study, we analyzed the blinded data of completers from approximately 20% of the planned trial enrollment and observed that a substantial
number of subjects discerned no difference between the test doses in the study (100 mg ketamine; 25 mg, 75 mg and 150 mg of Rel-1017
and placebo, all given orally). None of the tested drug arms in these subjects separated from the placebo range (subjects rate
test doses on a likability scale ranging from 0 to 100 with 0 implying large dislike, 40 to 60 implying neither like or dislike
(placebo range) and 100 implying large likability). Failure of the active control (100 mg oral ketamine) to separate from placebo
invalidates this study design.
Within the next 4 weeks, we plan to submit
to the FDA a new study design proposing a different active control to enable the trial to meet its objective of assessing the abuse
potential of Rel-1017. Alternate routes of administration of ketamine have shown improved bioavailability relative to oral ketamine.
As a result, it is our intention to investigate intranasal or intravenous administration in the revised protocol. Our expectation
is that we will be able to resume this portion of the Human Abuse Potential Program in the second quarter of this year.