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Large-Volume Subcutaneous Delivery

Large-Volume Subcutaneous Delivery

Large-Volume Subcutaneous Delivery

Clinical summary on the accuracy, safety, and efficacy of large-volume subcutaneous delivery

Why IV to SC?

IV Facts

  • More than 1 billion IVs are placed globally each year1.
  • Peripheral IV cannulation difficulty occurs in up to 24% of adult patients and 37% of pediatrics requiring a cannula.2

SC Advantages

Patient-Pharma-Physician-Payer

Is SC Delivery Safe and Effective?

A 2019 study12 concludes the following pharmacokinetic and safety data comparing IV vs. SC administration:

Safety:

“Treatment emergent AEs across all cycles occurred in 24 (96%) patients treated with PF-06801591 IV and in 15 (100%) treated with SC administration of the drug. Grade 3 or higher AEs occurred in 11 (44%) and 6 (40%) patients treated with PF-06801591 IV and SC, respectively.”12

Efficacy:

Efficacy-Large Volume Subcutaneous Delivery

Efficacy-Chart-Large-Volume-Subcutaneous-Delivery

“The safety and tolerability [of IV and SC] …appear to be comparable. Exposure following SC administration was within the expected efficacious dose range.” 12

How Does enFuse® Work?

enFuse technology – simplified

enFuse-technology-simplified

Clinical Summary

  • 4 Clinical Trials
  • 3 completed and 1 ongoing
  • 6 Products and 3 Pharma Partners
  • >600 Devices tested in clinical studies
  • Up to 3 devices worn simultaneously and delivered volume ranges 1.5 to 50mL

Outcomes

  • Bioequivalence met (all studies) 13 – No safety issues
  • 30% reduction in Adverse Events vs. standard of care13
  • No injection site reactions13
  • Improved Dose Accuracy, reduced Site Leakage13

Enable Injections, Inc.

Redefining drug delivery for the benefit of patients, providers, and partners.

Enable Injections is a clinical-stage company developing and manufacturing on-body delivery systems designed to improve the patient drug delivery experience. Enable’s enFuse® system subcutaneously delivers large volumes of up to 50 mL of high-viscosity therapeutics. Contact us to further discuss large volume subcutaneous delivery of large molecule medicines.

To learn more about Enable’s Manufacturing, click here.

Clinical summary on the accuracy, safety, and efficacy of large-volume subcutaneous delivery

Sources:

  1. Beecham, G, et al,. “Peripheral Line Placement.” StatPearls; 2021. (link)
  2. Rodriguez-Calero, M., et al. “Defining risk factors associated with difficult peripheral venous cannulation: a systematic review and meta-analysis.” Heart & Lung, Vol 49, issue 3, May 2020, pp 273-286. (link)
  3. Subcutaneous monoclonal antibody in cancer care: cost-consequence analysis of subcutaneous rituximab in patients with follicular lymphoma 5. De Cock, E; et al. (link)
  4. Switching from IV to SC IL-6 Receptor Inhibitor Therapy Shows No New Safety Signals, Jan 2021, (link)
  5. Update on the subcutaneous administration of rituximab in Canadian cancer centers (link)
  6. The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection, (link)
  7. Switching from IV to SC Rituximab Saves Staff Time and Money (link)
  8. FDA H.R.3590 Patient Protection and Affordable Care Act (link)
  9. Efficacy of SC formulations: Comparison of SC versus IV administration of rituximab as maintenance treatment for follicular lymphoma: results from a 2-stage, phase IB study (link)
  10. Payer Perspectives on Intravenous versus Subcutaneous Administration of Drugs 2021 (link)
  11. Health Economics study, 2019. Ref. Enable Injections.
  12. Johnson, M., et al. “Assessment of SC vs IV Administration of Anti-PD-1 Antibody PF-06801591 in Patients with Advanced Solid Tumors, a Ph 1 Dose Escalation Trial.” JAMA Oncology, 30MAY2019. (link)
  13. Data on file, Enable Injections, Inc.