Relivar

Relivar, a buccal tablet for symptomatic management of neuropathic pain, contains the active ingredient, dronabinol (or THC). THC has been clinically has been shown to be efficacious for neuropathic pain in numerous clinical trials which have been published in reputable peer-reviewed journals. Undesired psychoactivity associated with higher doses of the oral formulation has limited its utility for this indication.

Relivar aims to deliver the drug in the oral cavity by incorporating it into a tablet that adheres to the gum and releases the drug in the mouth. The benefits are two-fold:

      (1) promoting direct absorption through the gums, Relivar can achieve increased bioavailability and reduce the dose required for efficacy

      (2) reducing the amount of drug swallowed, and thereby reducing the amount of drug directly metabolized by the liver (first-pass metabolism), also reduces the amount of a potent psychoactive metabolite, Relivar can reduce side effects observed with commercial forms of the drug

Regulatory approval in the United States will depend on a Food and Drug Administration regulatory pathway, based in part on the known safety profile of dronabinol, to be complemented with additional clinical data for use in the new indication of neuropathic pain.

Relivar has successfully completed Proof of Concept Phase I clinical trials for safety and pharmacokinetics (results announced on April 14, 2009) which show proof of buccal absorption, though a combination of increased bioavailability and reduced ratio of the psychoactive metabolite.
 

Top of Page