- 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. ETtoday
"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
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
"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
"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
Cara management will host a conference call today at
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 atwww.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
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.
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
CONTACT: CORPORATE CONTACT:
Derek ChalmersPresident & CEO Cara Therapeutics, Inc.203-567-1500 INVESTOR CONTACT: Jesse BaumgartnerStern Investor Relations, Inc. 212-362-1200 [email protected] MEDIA CONTACT: Annie Starr6 Degrees 973-415-8838 [email protected]