scPharmaceuticals may provide physician-requested expanded access to its investigational products to patients with serious diseases who lack other therapeutic options, cannot join an active clinical trial of the investigational product, and where the potential benefits of the investigational product are greater than the known risks in the disease indication (as described by the criteria below).
Criteria Used for Considering Requests for Expanded Access
- The patient has a serious disease or condition with no comparable or satisfactory alternative therapy
- The potential benefit justifies the potential risks, and the potential risks are not unreasonable within the context of the disease or condition
- The initiation, conduct, or completion of clinical investigations will not be compromised by providing investigational drug for the requested use
- Adequate supply of investigational product is available
- A regulatory mechanism in the country or region to support expanded access exists
Process for Requesting Expanded Access
Patients interested in seeking expanded access to a scPharmaceuticals investigational product should talk to their physician. A treating physician may request information about applying for access to one of scPharmaceuticals investigational products by contacting scPharmaceuticals Medical Information by phone at +1 855-SCPHARMA (855-727-2762) or by email at firstname.lastname@example.org. scPharmaceuticals will acknowledge receipt of a request for expanded access within three business days and our experts will carefully review all expanded access requests in consideration of the above criteria. All physicians who receive scPharmaceuticals investigational product through expanded access are required to comply with all applicable laws and regulations, and contractual conditions, including those relating to safety reporting.