Relmada Therapeutics Inc (OTCMKTS:RLMD) reported that enrollment of subjects in its proof-of-concept pharmacokinetic trial with innovative formulations of ‘BuTab’, or ‘REL-1028’ being formulated for both opioid dependence and chronic pain indications has touched the halfway point. As previously announced, the company expects releasing top-line data in the second half of 2015.
The details
Sergio Traversa, the CEO of Relmada, said that the reaching halfway point in the proof-of-concept trials is an important milestone while advancing an oral formulation of BuTab. The new medication will compare favorably with existing formulations of buprenorphine. As a traditional drug consumed by mouth and moving down the intestinal tract, BuTab would highlight a considerable achievement in patient care and a noteworthy commercial prospect for Relmada. The company looks forward to release data from this trial in the second half of 2015.
The study
Relmada reported that the clinical trial is developed to evaluate the pharmacokinetics, safety, and tolerability of BuTab in healthy enrollments. As per the underlying scientific concept and the company’s previously performed successful preclinical activities, the main goal of this trial is to evaluate if buprenorphine can be administered orally and reach effective and safe blood levels via the gastrointestinal path of administration.
The scope
Relmada Therapeutics Inc (OTCMKTS:RLMD) stated that as of now there are no commercially available oral medications of buprenorphine that drives gastro-intestinal absorption. The results from this trial will lead to the design of following clinical pharmacology trials for opioid dependence. It will form a base for potential regulatory filing for respective indication along with the plan of a Phase III trial in chronic pain under the 505(b)(2) regulatory pathway.
In last trading session, the stock price of RLMD gained more than 4% to close the trading session at $2.03. The gains came at a share volume of 106,989 compared to average share volume of 65,688.
