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news.US-based Relmada Therapeutics has started a proof-of-concept pharmacokinetic trial with its new formulations of oral, enteric-coated buprenorphine (BuTab, or REL-1028) being developed for both chronic pain and opioid dependence indications.
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The trial is designed to evaluate the safety, tolerability, and pharmacokinetics of BuTab in healthy subjects.
Main objective of the trial is to assess if buprenorphine can be delivered orally and reach safe and effective blood levels through the gastrointestinal route of administration.
Results from the trial will inform the design of subsequent clinical pharmacology studies for opioid dependence and potential regulatory filing for this indication along with the design of a Phase III trial in chronic pain under the abbreviated 505(b)(2) regulatory pathway.
Relmada Therapeutics CEO Sergio Traversa said: "Our team is working to advance an oral formulation of BuTab that will compare favorably with currently marketed sublingual formulations of buprenorphine.
"With this advantage, BuTab would represent an important advance in patient care and a significant commercial opportunity for Relmada. We look forward to reporting results from this study during the second half of 2015."
Currently, there are no commercially available oral formulations of buprenorphine that result in gastro-intestinal absorption.
So far, buprenorphine has been widely used in several different formulations, but previously researchers have been unable to develop an effective oral formulation of buprenorphine that results in gastro-intestinal absorption due to the drug’s poor oral bioavailability.