Clinical trials are essential to the development of new therapies and ensuring the safety and efficacy of those therapies. scPharmaceuticals is pursuing clinical validation of the products in our pipeline.
scPharmaceuticals plans to initiate additional studies supporting the clinical development of the FUROSCIX® (furosemide injection) 80mg/10mL for subcutaneous administration program.
FREEDOM-HF: Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure. This is a multicenter, adaptive clinical trial with a prospective cohort and a propensity-matched historical control arm derived from administrative claims data to evaluate differences in resource utilization and direct medical costs between subjects receiving FUROSCIX® outside the hospital and patients receiving intravenous furosemide in the hospital setting for 30-days after being discharged from the emergency department. The study is designed to enroll up to 75 subjects in the FUROSCIX® cohort to detect a statistically significant difference in overall 30-day costs.
To learn more about FREEDOM-HF, please visit ClinicalTrials.gov.
Requesting Expanded Access
Currently, scPharmaceuticals does not provide access to investigational products outside of a clinical trial setting.
scPharmaceuticals may provide physician-requested expanded access to its investigational products for 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).
Expanded access may be appropriate when all of the following apply:
- Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or approval for the treatment indication.
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 how to request access to one of scPharmaceuticals’ investigational products by contacting scPharmaceuticals Medical Information:
firstname.lastname@example.org; +1 855-SCPHARMA (855-727-4276)
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.
Investigator-sponsored Studies (ISS)
For more information on our ISS program, please email email@example.com.
At scPharmaceuticals, we believe the future of healthcare lies within the talents of today’s scientists and technologists. With the goal of expanding skills and knowledge to improve standards of care and patient outcomes in the treatment of cardiovascular and infectious diseases, scPharmaceuticals may provide support for independent accredited and non-accredited educational activities for healthcare professionals.
Request Medical Information
We are committed to providing current, balanced, and accurate scientific information related to scPharmaceuticals’ products.
To submit a medical information request, please complete the form below and/or contact us at: 855-SCPHARMA (855-727-4272)