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news.Embera NeuroTherapeutics has met the primary endpoints of safety and tolerability in a phase 1 clinical trial of EMB-001, a potential novel treatment for addictions.
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EMB-001 is a patented combination product comprising metyrapone and oxazepam drugs, which have been approved by the US Food and Drug Administration.
It targets the stress response system as a novel approach to address addiction and relapse.
EMB-001 is believed to act by mechanisms different from those of current addiction treatments and is hypothesized to lower the increased activity in the stress response system induced by cues that support the acquisition and maintenance of addiction.
Under the randomized, double-blind, combined single and multiple rising dose phase 1 trial, Embera evaluated the safety and pharmacokinetics of EMB-001 in healthy adult volunteers who smoke.
The company measured pharmacokinetics of metyrapone, metyrapol (the primary active metabolite of metyrapone), and oxazepam in plasma.
Tobacco use and craving measures were examined as exploratory efficacy endpoints.
Embera NeuroTherapeutics chief medical officer Michael Detke said: "This is an important clinical milestone for Embera and we are encouraged by the successful completion of this study.
"The success of this study provides a strong rationale for the continued development of EMB-001 for the treatment of substance use disorders, an area in which there are very few treatments either approved or in clinical development."
Embera also tested EMB-001 in cocaine-dependent human subjects and nonclinical models of nicotine, cocaine and methamphetamine dependence.
Image: EMB-001 is believed to act by mechanisms different from those of current addiction treatments. Photo: courtesy of gubgib/FreeDigitalPhotos.net.