Potential Expanded Access Criteria:
As stated above, Sunovion does not currently provide Expanded Access to its investigational products. In the event that Sunovion may, in the future, consider a request for Expanded Access, each request would be evaluated in accordance with this Policy and would be required to meet the following criteria:
- The patient has a serious disease or condition, has exhausted all reasonable, available treatment options and is not eligible to participate in any appropriate clinical trial.
- The patient must meet any other pertinent medical criteria for access to the investigational product as established by the Sunovion medical professionals working on the drug development program.
- The investigational product must be in active clinical development and being studied in a similar disease state to that for which the Expanded Access is requested.
- There must be adequate supply of the investigational product to accommodate the needs of the Expanded Access program without interfering with ongoing and/or planned clinical trials.
- Expanded Access will not delay, interfere with or compromise ongoing clinical trials or the potential approval of the product.
- There is sufficient evidence that the potential benefits to the patient would likely outweigh the potential risks to the patient.
- There is adequate clinical data to support the appropriate dose (amount and frequency) for the investigational product’s use in the disease or condition.
- The Expanded Access request must be made by a physician who is qualified and licensed in the United States and who is knowledgeable in the treatment of the disease or condition.
- The patient is a resident of the United States.
- All applicable laws and regulations must be followed.
Process for making an Expanded Access request:
Requests for access to investigational products must be made by a qualified and licensed physician by contacting Sunovion at 800.739.0565 or firstname.lastname@example.org. The physician requesting Expanded Access must provide specific case information, including:
- Pertinent patient history. The physician will be requested not to provide the patient’s individually identifiable health information or protected health information.
- Scientific rationale for the potential benefits the investigational product may provide based on the available nonclinical and clinical data.
- A statement that the patient has exhausted reasonable approved therapy options, or the patient is no longer responsive to, or able to tolerate these therapies.
- A statement that there are no reasonable and viable therapy options.
Evaluation of Request(s):
Requests will be evaluated on an individual basis by medical and scientific professionals at Sunovion who are familiar with the available data for the investigational product. The medical and scientific professionals will evaluate the request based on the scientific evidence available to Sunovion at the time of the request and may review other information relevant to patient safety. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, as applicable, and to abide by all regulations and laws concerning patient safety.
Sunovion will make every effort to acknowledge requests that have been submitted in accordance with the above requirements within five (5) business days of receipt.
Once the investigational product is commercially available, Expanded Access will be discontinued as soon as feasible, subject to any legal or regulatory requirements.
Information regarding Sunovion’s clinical studies may be found at www.clinicaltrials.gov.
If a program is designed to provide access to a number of patients, Sunovion plans to abide by applicable regulations and laws to include information related to our Expanded Access activities on clinicaltrials.gov or other applicable registries.
Sunovion reserves the following rights, which may be exercised at any time without prior notice:
- The right to discontinue the provision of investigational product to a patient.
- The right to discontinue the Expanded Access program for any Sunovion investigational product.
- The right to revise, modify or retire this Policy.