- Comparator will be pentazocine, a Schedule IV opioid receptor agonist with lower abuse potential than common opioids
- Top-line data expected in fourth quarter of 2014
SHELTON, Conn., July 31, 2014 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain by selectively targeting peripheral kappa opioid receptors, today announced the initiation of a human abuse liability (HAL) trial of an intravenous formulation of its peripherally-selective kappa opioid agonist, CR845. The company expects to report top-line data from this trial in the fourth quarter of 2014.
"The initiation of this human abuse liability study is a key milestone in the development path for CR845," said Robert Medve, M.D., Chief Medical Officer of Cara Therapeutics. "Prescription opioid abuse is a worsening public health crisis. This trial will assess CR845's lower abuse potential, relative to pentazocine, a Schedule IV analgesic. We believe that this HAL study for CR845, if successful, combined with the analgesic efficacy already demonstrated in two Phase 2 surgical models, will underscore the potential for CR845 to provide a significant, highly differentiated advancement in pain care."
The HAL study is a double-blind, randomized, active- and placebo-controlled four-way crossover trial that will evaluate the abuse potential of I.V. CR845 in non-dependent, recreational polydrug users with lifetime and recent hallucinogenic drug use. The primary objective of the trial is 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 as a Schedule IV drug, indicative of reduced abuse liability compared to most other narcotics.
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 and most other narcotic 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.
About CR845
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.
Forward-looking Statements
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 expected timing for the Company's human abuse liability clinical trial of IV CR845, the design and the potential for successful results of the trial, the timing of the reporting of the topline results of the trial, as well as the potential future regulatory and development milestones for the Company's product candidates. 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.