Compassionate Use Of Investigational Medicines
Access to Investigational Medicines
Some patients with serious or life-threatening diseases may not be eligible for clinical trials and may not have other treatment options. Corcept may be able to offer one of our investigational medications to a patient who has exhausted other treatment options and who might benefit from our medications, provided that the criteria described below are met. This access includes investigational medications that are not approved for any purpose in the country of intended use and additionally covers the time between regulatory approval of an investigational product and its commercial availability. Corcept can offer patients access to investigational medications through Corcept clinical trials or through compassionate use.
Patients interested in access to Corcept investigational medications should speak with their physicians about their eligibility to enroll in any of Corcept’s clinical trials. Information about available trials can be accessed at ClinicalTrials.gov.
If the physician determines that the patient does not qualify for an ongoing clinical trial, Corcept may provide investigational medication through compassionate use, which is also known as expanded access. The physician should contact Corcept to make the request on behalf of the patient.
Procedure for Making a Request for an Investigational Medication
Corcept will acknowledge receipt of such request within one (1) business day.
General Criteria for Access to Corcept Investigational Medications
The risk-benefit of treatment with the investigational medications must be considered. Decisions regarding potential access to investigational medications can only be made with consideration of criteria including those listed below, and after discussions between the Corcept clinical team and the patient’s qualified treating physician.
- The medication is under investigation in one or more Corcept clinical studies.
- Sufficient evidence must exist to expect that the investigational agent will have an acceptable safety profile for the intended patient.
- There must be an adequate supply of the investigational medication so that compassionate use will not interfere with ongoing or planned clinical studies or with the supply of drug to patients already receiving the medicine through compassionate use.
- Use of the investigational medication must comply with FDA or applicable ex-US regulations and be approved by the treating physician’s institutional review board/ethics committee.
- Patients must have a serious or life-threatening disease or condition.
- Patients must have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available.
- Patients are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations.
- Patients must meet any other pertinent medical criteria, such as a disease similar to indication(s) under investigation by Corcept on the investigational medicine.
Treating Physician and Their Responsibilities
- The treating physician is properly licensed and qualified to administer the investigational medicine.
- The physician must agree in writing to comply with: a) Any applicable country-specific legal and regulatory requirements related to providing an investigational or unlicensed medicine under expanded access; and b) Any Corcept requirements in terms of medical criteria, safety reporting, drug supply/use, and protection of intellectual property.
How Decisions for Expanded Access Are Made at Corcept
Corcept is committed to a fair and impartial evaluation of each request for access to our investigational medications. All decisions are based solely on clinical circumstances. Whenever possible, patients will be referred to ongoing clinical trials as the primary way to access investigational medications.
Patients and treating physicians are advised that there is no guarantee of access to any specific investigational medicine through expanded access.