Relmada Therapeutics Inc (OTCMKTS:RLMD) said that it obtained a No Objection Letter from Health Canada to carry out the first pharmacokinetic trial with new formulations of oral and enteric-coated buprenorphine being developed for the cure of both opioid dependence and chronic pain.
Sergio Traversa, the CEO of Relmada Therapeutics said that as now they have obtained the Health Canada clearance, the company’s second product candidate is prepared to enter clinical studies in 2Q2015. The management recorded rapid progress in the pain relief portfolio. It indicates that the company has an experienced and well-qualified team. As of now, the objective of Relmada is to show that oral BuTab can provide same positive results as that shown by currently sold sublingual formulations of ‘buprenorphine.’ The new candidate has a significant commercial potential.
The development in trials
Relmada is planning a Phase 1 trial prepared to evaluate the safety, tolerability and last but not the least, pharmacokinetics of BuTab in healthy enrollments. The pharmacokinetic and safety data from Phase 1 trial will report the design of following clinical pharmacology trials for opioid dependence. Also, it will form a base for potential regulatory filing.
Buprenorphine has been extensively used in numerous different formulations. However, it has not been able to break the form of traditional oral capsule and tablet due to poor oral bioavailability. Relmada’s lead product candidate is formulated to rise above this limitation by avoiding the metabolism that is witnessed in the upper gastrointestinal tract. The new feature will allow medication to be absorbed into the bloodstream. Buprenorphine has been stated as having lower abuse potential compared to Schedule II drugs and therefore is categorized under Schedule III controlled substance. It can be called as a ‘mu-opioid receptor partial agonist.’ It is a form of a potent analgesic with a long duration of action compared to other analgesics.