Cara Therapeutics Inc (NASDAQ:CARA) announced positive results from its Human Abuse Liability (HAL) trial ofCR845, a first-in-class peripherally-selective kappa opioid agonist, on Wednesday, October 29th. This new drug is being hailed as the first in a new class of pain medications with very low potential for addiction or abuse.
Cara Therapeutics is up $1.22 to $9.87 in trading on Wednesday morning.
Details on Cara Therapeutics opoid agonist trial
The top-line results released today demonstrated that therapeutic and supratherapeutic doses of I.V. CR845 met the trial’s primary endpoint with statistically significant lower “drug liking” scores as measured by visual analog scale (VAS) Emax (p <0.0001) when compared to intravenous pentazocine, a Schedule IV opioid receptor agonist. Intravenous CR845 also demonstrated highly statistically significant lower “feeling high” and “overall liking” scores (p <0.0001) relative to pentazocine. Furthermore, both doses of intravenous CR845 were rated equivalent to placebo on “overall drug liking” and “take drug again” measures.
Statement from lead trial investigator
“Given the results seen in the HAL trial and in the Phase 2 trials conducted to date, I.V. CR845 has the potential to offer a new and safer approach to the treatment of acute pain,” noted Lynn Webster, M.D., lead investigator for the HAL trial at PRA Health Sciences. “CR845 differs from other opioids because it works on kappa opioid receptors that are localized on peripheral nerve endings. As such, CR845 doesn’t enter patients’ brains and doesn’t cause side effects, such as euphoria, respiratory depression, nausea and vomiting that are common with existing opioids. The data accumulated to date suggest that CR845 could be a significant new development in pain management.”
Statement from Cara Therapeutics CEO
“We are extremely pleased with the results from this human abuse liability trial, which suggest the potential for CR845 to be the first Schedule V or non-scheduled peripheral opioid for acute pain,” commented Derek Chalmers, President and Chief Executive Officer of Cara Therapeutics Inc (NASDAQ:CARA). “The results are especially encouraging because CR845 was administered by rapid intravenous injection, which provides the fastest delivery of the highest level of drug into the bloodstream, a critical determinant of abuse liability. With positive analgesic efficacy data from two previous Phase 2 trials of I.V. CR845 and these positive HAL results now in hand, we look forward to advancing I.V. CR845 into Phase 3 clinical trials in early 2015.”