Cara Therapeutics Announces Positive Results From Human Abuse Liability Trial Of Peripheral Opioid For Acute Pain, I.V. CR845

Cara Therapeutics, Inc.

, a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain without eliciting typical opioid (narcotic) side effects, today announced positive results from its Human Abuse Liability (HAL) trial of an intravenous (I.V.) formulation of CR845, a first-in-class peripherally-selective kappa opioid agonist. "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," said Derek Chalmers, Ph.D, D.Sc., President and Chief Executive Officer of Cara Therapeutics. "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." Top-line results showed that therapeutic and supratherapeutic doses of I.V. CR845 met the trial's primary endpoint by demonstrating highly statistically significant lower "drug liking" scores as measured by visual analog scale (VAS) Emax (p <0.0001) when compared to I.V. pentazocine, a Schedule IV opioid receptor agonist. I.V. CR845 also demonstrated highly statistically significant lower "feeling high" and "overall liking" scores (p <0.0001) as compared to pentazocine. Additionally, both doses of I.V. CR845 were rated equivalent to placebo on "overall drug liking" and "take drug again" measures. "Drug liking," "feeling high," "overall liking" and "take drug again" scores are standard subjective measures recommended by the U.S. Food and Drug Administration (FDA) to assess a drug's abuse liability, both for recommended scheduling as well as labeling. "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," said Lynn Webster, M.D., lead investigator for the HAL trial at PRA Health Sciences and immediate past president of the American Academy of Pain Medicine. "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." According to The Centers for Disease Control and Prevention (CDC), 46 people die each day in the U.S. from an overdose of prescription pain medications. Statistics compiled by the National Institute on Drug Abuse (NIDA) indicate that young adults (age 18 to 25) are the biggest abusers of prescription opioid pain relievers. In 2010, almost 3,000 young adults died from prescription drug (mainly opioid) overdoses—more than died from overdoses of any other drug, including heroin and cocaine combined—and many more needed emergency treatment. The total cost of prescription opioid abuse to the U.S. was $55.7 billion in 2007. "One of the biggest challenges we face in providing optimal pain care is that many of our most effective medications have such high abuse potential," said Bob Twillman, Ph.D., Deputy Executive Director and Director of Policy and Advocacy for the American Academy of Pain Management. "An opioid analgesic that appears to reduce abuse potential to this extent is truly unprecedented. I am very hopeful that this means we will soon be able to substantially reduce the burden of pain experienced by patients without exposing them to significant risk of developing a substance abuse problem."