The Food and Drug Administration (FDA) has scheduled an end-of-phase 2 clinical trial meeting for a sublingual formulation of racemic ketamine (Wafermine; iX Biopharma, Singapore) for treatment of moderate-to-severe acute pain.
The therapy contains R and S isomers of ketamine in equal proportions In a phase 2b randomized placebo-controlled study (NCT03246971) participants experienced analgesic efficacy from ketamine with safety and tolerability for treatment of acute post-operative pain after abdominoplasty or bunionectomy. In pharmacokinetic studies (NCT01377831), sublingual delivery increased bioavailability of active compounds when compared to oral administration, while avoiding excessively high peak plasma concentrations typical of IV bolus dosing.
"Wafermine provides an attractive non-opioid approach for the treatment of acute pain by targeting the NMDA receptor and would represent the first ketamine drug for the indication of pain,” said Dr. Janakan Krishnarajah, chief medical officer, iX Biopharma. “Additionally, racemic ketamine's novel mechanism of action has been demonstrated to have a strong and rapid anti-depressant effect in patients with treatment-resistant depression. We believe Wafermine has tremendous prospects given its potential to address these two prevalent conditions with significant medical need.”
Paul M. Elsbernd, MD; Kathryn J. Lago, DO; Tatjana P. Calvano, DO; and John H. Sladky, MD
Chia-Chun Chiang, MD, and Juliana VanderPluym, MD, FRCP, FAHS
James Geyer, MD, and Paul Cox