Relmada Therapeutics Inc (OTCMKTS:RLMD) reported that it is advancing with enrollment process in its proof-of-concept study with unique formulations of enteric-coated oral buprenorphine. The medication is being developed to cure chronic pain and opioid dependence. The enrollment in the study has reached the halfway point. Also, the company reiterated its previous guidance of reporting top-line data in 2H2015.
The CEO Sergio Traversa said that the advancement in the enrollment process in the proof-of-concept study highlights another noteworthy milestone as the company continues to works on oral formulation of BuTab. The lead candidate of Relmada compares positively with presently marketed medications of buprenorphine.
BuTab will be taken by mouth and move through the body to intestinal tract where it will finally be absorbed. The advancement of BuTab represents a major commercial opportunity for company.
The clinical study
Relmada announced that the study is planned to gauge the safety, acceptability, and pharmacokinetics of drug candidate ‘BuTab’ in healthy subjects. The primary endpoint is to know if buprenorphine can be given orally. In addition, the study will assess if it reaches effective and safe blood levels when administered through the gastrointestinal route.
The developments holds significant value for Relmada as it is trying to make a commercially available oral drug of buprenorphine that supports gastro-intestinal absorption. The pivotal study’s data will be considered for planning subsequent clinical pharmacology studies to heal opioid dependence and plan regulatory submission for this indication.
Relmada Therapeutics is working to develop novel formulations of proven drugs together with new chemical firms. It has a diversified portfolio which contains four lead products, REL-1028, REL-1015, REL-1017 and REL-1021. The development plans are directed by the internationally known scientific expertise of leading research team.
In early morning trade on Tuesday, the stock price of Relmada Therapeutics Inc (OTCMKTS:RLMD) is trading flat at $1.69. However, in last trading session, the declined more than 8% at a share volume of 39,043.