WHA

Enbumyst (bumetanide nasal spray)

Indications for Prior Authorization

Enbumyst (bumetanide nasal spray)
  • For diagnosis of Edema Associated with Congestive Heart Failure, Hepatic and Renal Disease, including Nephrotic Syndrome
    Indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome in adults.

Criteria

Enbumyst

Prior Authorization

Length of Approval: 1 Month(s)

  • Diagnosis of edema associated with congestive heart failure, hepatic disease, renal disease, or nephrotic syndrome
    • AND
  • Used for short-term treatment, when the use of IV or oral bumetanide, is not feasible (e.g., access issues, resistance, poor gastrointestinal absorption, delayed onset)

  • Guideline ID
    GL-421281

  • Formulary
    Premium

  • Effective date
    Dec 1, 2025

  • P&T approval date
    Nov 20, 2025

P & T Revisions

2025-11-11

  1. Enbumyst Prescribing Information. Corstasis Therapeutics. Henderson, NV. September 2025.
  2. FDA Approves Cortasis Nasal Spray, Enbumyst, for Edema. Available at: https://www.pharmtech.com/view/fda-approves-cortasis-nasal-spray-enbumyst-for-edema. Accessed October 14, 2025.
  3. Enbumyst. Available at: https://enbumyst.com. Accessed October 14, 2025.
  4. FDA Approves Bumetanide Nasal Spray for Edema With Heart Failure, Hepatic and Renal Disease. Available at: https://www.pharmacytimes.com/view/fda-approves-bumetanide-nasal-spray-for-edema-with-heart-failure-hepatic-and-renal-disease. Accessed October 14, 2025.
  5. RSQ-777-02: New Nasal Spray Form of Bumetanide as Effective as Oral and IV Forms in Patients Without HF or HF Risk. Available at: https://www.acc.org/latest-in-cardiology/articles/2024/11/13/21/17/mon-930am-rsq77702-aha-2024. Accessed October 14, 2025.
  6. FDA Approves Enbumyst, an Intranasal Formulation of Bumetanide. Available at: https://www.gastroenterologyadvisor.com/news/fda-approves-enbumyst-an-intranasal-formulation-of-bumetanide/. Accessed October 14, 2025.
  7. Novel Bumetanide Nasal Spray Offers Potential Alternative to Oral and IV Diuretics in Phase 1 Trial. Available at: https://medicaldialogues.in/cardiology-ctvs/news/novel-bumetanide-nasal-spray-offers-potential-alternative-to-oral-and-iv-diuretics-in-phase-1-trial-139341. Accessed October 14, 2025.
  8. Novel Intranasal Loop Diuretic. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC10149651/. Accessed October 14, 2025.
  9. Bumetanide Nasal Spray Equivalent to Oral, IV Forms for Heart Failure. Available at: https://www.hcplive.com/view/bumetanide-nasal-spray-equivalent-to-oral-iv-forms-for-heart-failure. Accessed October 14, 2025.
  10. Randomized Study Comparing a Novel Intranasal Formulation of Bumetanide With Oral and Intravenous Formulations. Available at: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.072949. Accessed October 14, 2025.
  1. A nasal spray treatment for edema in these patients, Corstasis said, may help bridge the gap between oral loop and intravenous (IV) diuretics. The former can be limited by delayed onset and poor gastrointestinal absorption, while the latter requires administration in a hospital or infusion setting, using resources and increasing healthcare expenditures (1). Conversely, Enbumyst has been designed as an outpatient, self-administered therapy. [2]
  2. Enbumyst demonstrated similar effects on diuresis, natriuresis, and urinary potassium excretion as oral bumetanide tablets and IV injection [3]
  3. Oral loop diuretics, for which the FDA has approved a series of products for treating edema, are recommended to reduce morbidity. They work by inhibiting salt reabsorption, allowing for greater water excretion and reducing swelling. However, adverse effects are possible with the use of such diuretics, including poor gastrointestinal absorption and delayed onset. Furthermore, IV diuretics require an inpatient hospital or infusion setting, which is associated with higher health care spending and more intensive resource utilization. Resistance to such products is also a palpable concern, necessitating more effective options. [4]
  4. A new nasal spray form of bumetanide may reduce the tissue swelling caused by heart failure (HF) as effectively as the standard oral and intravenous formulations of the loop diuretic, based on findings from the RSQ-777-02 trial [5]
  5. Findings showed the effect of a 2mg dose of Enbumyst on diuresis, natriuresis and potassium urine excretion over 0 to 8 hours and 0 to 24 hours was similar to that of 2mg bumetanide oral tablet and 2mg bumetanide IV injection [6]
  6. The phase 1 clinical study, evaluated a novel intranasal formulation of bumetanide, demonstrating its safety and pharmacokinetic profile comparable to established oral and intravenous formulations. [7]
  7. Patients may include those demonstrating decreased responsiveness to oral diuretics owing to suspected gastrointestinal impairment or in whom an oral route or intravenous route of administration is not practical. [8]
  8. RSQ-777-02 trial, administered nasal, oral, and intravenous bumetanide to each participant in a varied order and monitored study participants on-site for 10 days. [9]
  9. Participants were housed in the research facility for 10 consecutive days. A 48-hour washout period was applied between each treatment period. All meals and fluid intake were monitored. Participants were assigned to 1 of 4 treatment sequences across 5 periods: (1) R-T-R-T-IV, (2) T-R-T-R-IV, (3) IV-R-T-R-T, and (4) IV-T-R-T-R. In these sequences, “R” represents the reference oral bumetanide (2 mg), “T” represents the test BNS (2 mg), and “IV” denotes IV bumetanide (2 mg). Participants were housed in the research facility for 10 consecutive days. A 48-hour washout period was applied between each treatment period. All meals and fluid intake were monitored. BNS was delivered by a nurse, alternating nostrils over a 2-minute period. [10]
  • 2025-11-11: New PA UM Criteria for Enbumyst