Pulse Newsletter | Volume 7 - Issue 20

FDA Approves Enbumyst™ Nasal Spray for Treatment of Edema

On September 15, 2025, the U.S. Food and Drug Administration (FDA) approved Enbumyst™ (bumetanide) nasal spray for the treatment of adult patients with edema associated with congestive heart failure, liver and kidney disease. Edema is a type of swelling caused by excess fluid in the body that mainly affects the legs, ankles, and feet, but can occur anywhere and cause shortness of breath and difficulty breathing. Enbumyst™ is a loop diuretic that works by removing excess fluid from the body and offers an administration alternative to oral or intravenous forms of loop diuretics. Oral bumetanide takes longer to work in the body compared to intravenous or nasal bumetanide, and unlike the oral or nasal dosage forms, intravenous bumetanide requires administration by a healthcare professional in a clinic or hospital setting. 

Enbumyst™ is a nasal spray that can be self-administered. It is available in a 6-pack or 12-pack containing single-use unit doses of 0.5mg each of bumetanide. The recommended daily dose is 0.5mg to 2mg administered once daily. Enbumyst™ is not intended to be used long-term, and if additional therapy with loop diuretics is needed, changing to an oral dosage form is recommended. The safety and efficacy of Enbumyst™ was demonstrated in an open-label, single-and repeat-dose study of 84 healthy subject participants. The safety profile of nasal bumetanide is similar to that of oral bumetanide, with no adverse reactions reported that were related specifically to the nasal route of administration of the medication. Enbumyst™ is expected to be available in late 2025.

ACIP Announces COVID-19 Immunization Recommendations for the 2025-2026 Season

On September 19, 2025, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) announced their recommendation for COVID-19 vaccination for the 2025-2026 season. ACIP is recommending that the decision to be immunized against COVID-19 be made on a case-by-case basis after analysis of risk versus benefit in consultation with the individual’s health care provider. This recommendation applies to adults and pediatric individuals 6 months and older. The recommendation by ACIP differs from the current FDA-approved indications for 2025-2026 COVID-19 vaccines, which are approved only for those 65 years and older or those individuals with an underlying medical condition putting them at higher risk for severe COVID-19 infection. Underlying medical conditions that put an individual at higher risk for severe COVID-19 infection include, but are not limited to, asthma, cancer, chronic kidney disease, chronic lung disease, chronic liver disease, cystic fibrosis, diabetes, cerebrovascular disease, epilepsy, hemophilia, certain heart conditions, human immunodeficiency virus (HIV), certain mental health conditions, certain neurological conditions, obesity, overweight, pregnancy, sickle cell disease, smoking, tuberculosis, and suppressed immune system. Individuals at higher risk of exposure to COVID-19, such as healthcare workers, and individuals who are in the same household as those who may be at high risk of severe COVID-19 infection also fall under FDA approval. For the 2025-2026 season, the following COVID-19 vaccines are available: Comirnaty, Spikevax, mNEXSPIKE, and Nuvaxovid. While they are all FDA-approved for use in adults 65 years and older, the minimum age varies by product for those younger than 65 with high-risk underlying medical conditions. In this population, Comirnaty is FDA-approved for those 5 years and older, and Spikevax is approved for patients as young as 6 months. mNEXSPIKE and Nuvaxovid are approved for patients 12 years and older.

Per ACIP guidance, individuals outside of the FDA-approved indications for COVID-19 vaccination (including those aged 6 months to 64 years old without a qualifying underlying medical condition) may receive the COVID-19 vaccine “off-label” as recommended by their doctor. The safety and efficacy profile of the COVID-19 vaccines remains the same as in previous years, and the vaccine remains effective in lowering risk of hospitalization and severe infection due to COVID-19. Common adverse reactions include injection site reaction, fatigue, fever, headache, joint pain, and vomiting. Uncommon, but serious, side effects such as inflammation of the heart muscle and Guillain-Barré syndrome (a neurological disorder) have been reported.

FDA Grants Accelerated Approval for First Treatment for Barth Syndrome

On September 19, 2025, the FDA granted accelerated approval for Forzinity™ (elamipretide) injection for improvement of muscle strength in adult and pediatric patients who weigh at least 67 pounds with Barth syndrome. The FDA can grant an accelerated approval to a drug that meets an unmet need in the market and treats a serious medical condition for which there are few or no other drugs available for patients. Barth syndrome is a rare genetic mitochondrial disorder that affects the body’s ability to produce cellular energy, which can negatively impact the heart and other skeletal muscles of the body. It typically presents in infancy or early childhood and can be confirmed by genetic testing. Barth syndrome is more common in males than females, and there are currently no other treatments available.

Forzinity™ is injected subcutaneously (under the skin) in the stomach or outer thigh once a day at the same time each day. Patients with severe kidney impairment require lower dosing of the drug. Forzinity™ is supplied as single-patient-use vials, and each vial of Forzinity™ contains enough medication for more than 1 dose. Forzinity™ may be self-administered by a patient or caregiver after proper instruction from their health care provider. Approval by the FDA based on the results of a double-blind, placebo-controlled crossover trial including 12 male patients with confirmed diagnosis of Barth syndrome. Patients were randomly selected for treatment with Forzinity™ followed by placebo or placebo followed by Forzinity™ for 12 weeks, after a 4-week washout period. Forzinity™ demonstrated improvement in knee muscle strength, meeting a clinical endpoint in the study. Increased strength of the muscles of the leg and knee may benefit the ability of patients to stand and walk more effectively, and the FDA is requiring post-approval studies to confirm that patients do indeed benefit accordingly. Injection site reactions were the most common side effects, including pain, redness, and swelling at the injection site. Forzinity™ is expected to be available in late 2025. 

New FDA Approvals

New Drug: Bondlido® (lidocaine)

Transdermal patch approved for the treatment of adult patients with post-herpetic neuralgia (nerve pain associated with shingles). [9/24/2025 – MEDRx USA, Inc.]

New Generics Entering the Marketplace

Endometrin® (progesterone)

Indication: For the treatment of infertility to support embryo implantation and early pregnancy

Dosage Form/Strength: 100mg vaginal insert

Average Wholesale Price (AWP): Generic = $348/box | Brand = $371/box