US-based clinical-stage pharmaceutical firm Embera NeuroTherapeutics has reported positive topline data from the Phase Ib cocaine interaction study of a patented combination product EMB-001.
It is reported that the product was found to be well-tolerated and no new safety signals were observed.
EMB-001 includes two FDA-approved medications, namely the cortisol synthesis inhibitor metyrapone and the benzodiazepine oxazepam.
It is presumed to act by mechanisms exempt from those of existing addiction treatments and is hypothesised to reduce the increased activity in the stress response system, induced by cues which contribute to addiction maintenance.
The study was designed to assess the safety, tolerability and pharmacokinetic effects of EMB-001 co-administered with cocaine.
In July last year, Embera received an $11.1m grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH) to fund this study.
Emberachief medical officer Michael Detke said: “No serious adverse events occurred when combining EMB-001 and cocaine, indicating that EMB-001 can be used safely in active cocaine users.
“We have previously shown promising preliminary efficacy of EMB-001 in a published pilot study in cocaine-dependent human subjects.
“With the successful completion of this cocaine interaction trial, these studies pave the way for our planned Phase II clinical trial to evaluate the efficacy of EMB-001 in patients with cocaine use disorder.”
The Phase Ib trial study enrolled 18 non-treatment seeking adults within aged 21-55 with cocaine use disorder.
Subjects were randomised to receive EMB-001 or placebo twice daily for six days, and on the seventh day received a final morning dose of EMB-001 or placebo with an IV infusion of cocaine.
After a seven-day washout period, they underwent a second seven-day dosing period with EMB-001 or placebo, whichever was not administered during the first dosing period with a cocaine infusion on the seventh day.
The study recorded no clinically significant changes in blood pressure or heart rate on the subjects when cocaine was co-administered with EMB-001 versus placebo.
The most common treatment-emergent adverse events (TEAEs) recorded are euphoric mood, somnolence and headache.
The standard mild-moderate-severe clinical trial rating scale rated 93% of all these TEAEs as mild.
According to a report in 2015, there are 1.9 million cocaine users aged 12 or older in the US alone.
There are currently no approved medications for the treatment of cocaine use disorder.