- Trial meets primary endpoint with I.V. CR845 showing highly statistically significant reductions (p <0.0001) in scores for "drug liking," as well as "feeling high", "overall liking", and "take drug again" when compared to I.V. pentazocine, a Schedule IV opioid analgesic
- Results suggest potential for I.V. CR845 to be first Schedule V or non-scheduled peripheral opioid for acute pain
- Conference Call/Webcast at 9:00 a.m. ET today
SHELTON, Conn., Oct. 29, 2014 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA), 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."
Cara management will host a conference call today at 9:00 a.m. ET to discuss the results from the Human Abuse Liability Trial.
To participate in the conference call, please dial 855-445-2816 (domestic) or 484-756-4300 (international) and refer to conference ID 28180710. A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com.
An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.
The HAL trial was a double-blind, randomized, active- and placebo-controlled four-way crossover trial that evaluated the abuse potential of I.V. CR845 in 40 non-dependent, recreational polydrug users with lifetime and recent hallucinogenic drug use. The primary objective of the trial was to measure the relative abuse potential of both a therapeutic and supratherapeutic dose of CR845, compared to an intravenous dose of pentazocine. Pentazocine is a mixed-action kappa and mu opioid receptor agonist used clinically in the treatment of moderate-to-severe pain and is classified by the Drug Enforcement Agency (DEA) as a Schedule IV drug, indicative of reduced abuse liability compared to most other opioids.
About Drug Scheduling
Under the Controlled Substances Act of 1970, certain types of drugs, substances, or chemicals used to make drugs are classified by the DEA into one of five distinct categories or schedules, depending upon the drug's acceptable medical use and the drug's abuse or dependency potential. The risk of abuse is a determinate factor in the scheduling of the drug. For example, Schedule I drugs, such as heroin, are considered the most dangerous class of drugs with the highest potential for abuse, potentially severe psychological and/or physical dependence, and are considered to have no acceptable medical use. Schedule II drugs, such as oxycodone, hydrocodone, and most other opioid analgesics, are considered to have a high potential for abuse, but are medically acceptable and have the highest degree of restrictions on their prescription and use. Increasing drug schedule numbers, from Schedule II to Schedule III, etc., indicate progressively lower abuse potential and a lesser degree of legal restrictions, with Schedule V drugs having the least potential for abuse, and, therefore, the lowest degree of legal restrictions on prescription and use, apart from unscheduled drugs.
CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in pain intensity and opioid-related side effects. In over 400 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body's peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the potential future scheduling of I.V. CR845 by the DEA if the drug receives regulatory approval, the potential future regulatory approval of I.V. CR845, the ability of I.V. CR845 to reduce patients' pain burden without exposing them to significant risk of a substance abuse problem and the expected timing for the Company's Phase 3 clinical trials of I.V. CR845. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics' filings with the Securities and Exchange Commission, including the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2013 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT: CORPORATE CONTACT: Derek Chalmers President & CEO Cara Therapeutics, Inc. 203-567-1500 INVESTOR CONTACT: Jesse Baumgartner Stern Investor Relations, Inc. 212-362-1200 Jesse@sternir.com MEDIA CONTACT: Annie Starr 6 Degrees 973-415-8838 firstname.lastname@example.org