Relmada Therapeutics, Inc., a clinical-stage company developing novel therapies for the treatment of chronic pain, has received a No Objection Letter (NOL) from Health Canada to conduct the first pharmacokinetic study with novel formulations of oral, enteric-coated buprenorphine (BuTab, REL-1028) being developed for the treatment of both chronic pain and opioid dependence.
“Following Health Canada clearance, our second product candidate is about to enter clinical trials during the second quarter of 2015,” stated Sergio Traversa, CEO of Relmada Therapeutics. “The rapid progress of our pain relief portfolio this year is a testament to the experienced and talented team we have in place at Relmada Therapeutics. If we can demonstrate that oral BuTab compares favorably with currently marketed sublingual formulations of buprenorphine, we believe that it has significant commercial potential.”
The company is planning a phase 1 study designed to assess the safety, tolerability, and pharmacokinetics of BuTab in healthy subjects. The safety and pharmacokinetic data from this study 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 3 study in chronic pain under the abbreviated 505(b)(2) regulatory pathway.
Buprenorphine has been widely used in several different formulations, but not by the more traditional oral capsule/tablet route due to historically poor oral bioavailability. Relmada’s BuTab product candidate is designed to overcome this limitation by avoiding the metabolism that normally occurs in the upper gastrointestinal tract, therefore allowing it to be absorbed into the bloodstream. Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics. Buprenorphine is a mu-opioid receptor partial agonist and a potent analgesic with a relatively long duration of action.
Relmada Therapeutics is a clinical-stage, publicly traded specialty pharmaceutical company developing novel versions of proven drug products together with new chemical entities that potentially address areas of high unmet medical need in the treatment of pain.