Cara Therapeutics is committed to the development and commercialization of novel therapies for the treatment of chronic pruritic conditions. To do this, we conduct clinical trials to assess the safety and efficacy of our investigational products. For a list of clinical trials currently recruiting patients, please visit www.clinicaltrials.gov.
Clinical trials generate data that may allow us to apply for approval of our therapies for commercialization from regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Regulatory approval of our products may ultimately provide broader access to our medicines.
However, we recognize there are circumstances when there is a need for expanded access to investigational therapies prior to regulatory approval. When considering expanded access, Cara considers guidelines from the FDA and from regulatory agencies outside of the United States. Expanded access may be appropriate when all of the following apply:
- A patient has a serious disease or condition
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition
- Enrollment in a clinical trial is not possible
- The potential benefit justifies the potential risks of the investigational treatment
- Providing the investigational therapy will not interfere with clinical development or potential regulatory approval for the treatment indication
To request the use of an investigational therapy from Cara Therapeutics through an expanded access program, health care providers should contact Medical Affairs at email@example.com. A representative from Cara Therapeutics will acknowledge receipt of the request within 3 business days.