What is the new FDA approved nasal spray for various conditions?

October 8, 2025 •

2 min read

Since August 2024, the U.S. Food and Drug Administration (FDA) has approved several significant new nasal sprays, providing innovative delivery methods for conditions previously treated with injections or oral medication. This includes what is the new FDA approved nasal spray for anaphylaxis, a novel treatment for edema, and expanded use for a depression medication.

Quick Summary

Recent FDA approvals have introduced several new nasal sprays, including Neffy for anaphylaxis, Enbumyst for edema, and an expanded approval for Spravato in depression. These innovative medications offer needle-free or fast-acting alternatives for critical and chronic conditions, enhancing convenience and patient options.

Key Points

Neffy is the first needle-free emergency treatment for anaphylaxis: It was approved in August 2024 for those weighing 66+ lbs, and a lower dose for children (33-66 lbs) was approved in March 2025.
Enbumyst is a fast-acting, self-administered diuretic for edema: Approved in September 2025, it is used for fluid retention associated with heart, liver, or kidney disease.
SPRAVATO® can now be used alone for treatment-resistant depression: An expanded approval in January 2025 allows esketamine nasal spray to be used as a monotherapy.
FluMist® vaccine is now approved for self-administration: The expanded approval in September 2024 simplifies vaccine delivery for eligible individuals, effective for the 2025-2026 flu season.
Opioid overdose reversal has also seen nasal spray advancements: Prescribable Opvee (nalmefene) was approved in May 2023, while OTC naloxone sprays (Narcan, RiVive) received approval in 2023.
Nasal sprays offer easier, faster drug delivery: This route of administration can improve patient compliance and speed of action, particularly in emergencies.

Neffy (Epinephrine Nasal Spray) for Anaphylaxis

Neffy (epinephrine nasal spray) received FDA approval in August 2024 as the first needle-free alternative to auto-injectors for treating anaphylaxis. This emergency treatment is approved for adults and children weighing 66 pounds or more. A subsequent approval in March 2025 introduced a lower dose for children weighing 33 to 66 pounds, making this non-invasive option available to a broader pediatric population. Neffy has demonstrated comparable epinephrine blood concentrations and effects to auto-injectors.

Enbumyst (Bumetanide Nasal Spray) for Edema

Approved in September 2025, Enbumyst is the first self-administered intranasal diuretic for adults with edema due to heart, liver, or kidney disease. It offers a faster absorption rate than oral bumetanide and provides a convenient alternative to other diuretic forms. Enbumyst is intended for short-term use and requires monitoring for potential side effects like fluid and electrolyte imbalance.

Expanded Approval for SPRAVATO® (Esketamine) for Depression

In January 2025, SPRAVATO® (esketamine) nasal spray received expanded FDA approval for use as a monotherapy in adults with treatment-resistant depression (TRD). This means it can now be used on its own, whereas previously it required an accompanying oral antidepressant. SPRAVATO® targets the glutamate system and can offer rapid symptom improvement. It is administered in a certified healthcare setting due to potential risks.

FluMist® (Influenza Vaccine) for Self-Administration

The FDA approved a significant change for the FluMist® nasal spray vaccine in September 2024, permitting self- or caregiver-administration starting with the 2025-2026 flu season. This update enhances convenience and access for eligible individuals aged 2 through 49.

Comparison of Recent Nasal Spray Approvals


Medication	Primary Condition	Active Ingredient	FDA Approval	Administration
Neffy	Anaphylaxis	Epinephrine	Aug 2024 (2mg); Mar 2025 (1mg)	Needle-free nasal spray, single dose per nostril
Enbumyst	Edema (fluid retention)	Bumetanide	Sep 2025	Self-administered nasal spray, once daily
SPRAVATO®	Treatment-Resistant Depression	Esketamine	Jan 2025 (Expanded use as monotherapy)	Administered in a certified healthcare setting
FluMist®	Influenza Prevention	Weakened Live Influenza Viruses	Sep 2024 (Expanded self-administration)	Self- or caregiver-administered (starting 2025-26 flu season)
Opvee	Opioid Overdose Reversal	Nalmefene	May 2023	Prescription nasal spray, for emergency use
RiVive	Opioid Overdose Reversal	Naloxone	Jul 2023	Over-the-counter nasal spray, for emergency use

Conclusion

The recent FDA approvals of various nasal sprays represent valuable advancements in medical treatment, offering more convenient and accessible options for a range of conditions. From emergency anaphylaxis treatment with Neffy to faster edema management with Enbumyst, these innovations address critical needs and improve the patient experience. The expanded use of SPRAVATO® for depression and the self-administration option for FluMist® further highlight the versatility and impact of this drug delivery method, ultimately enhancing patient care by providing easier and faster treatment options.

Learn more about recent drug approvals on the official FDA website.

Frequently Asked Questions

Neffy is an epinephrine nasal spray approved by the FDA in 2024 and 2025 for the emergency treatment of anaphylaxis. It provides a needle-free alternative to traditional auto-injectors.

Enbumyst (bumetanide nasal spray) was approved by the FDA in September 2025 for the treatment of edema (fluid retention) in adults with congestive heart failure, liver disease, or kidney disease.

In January 2025, the FDA approved SPRAVATO® for use as a monotherapy for treatment-resistant depression (TRD), meaning it no longer requires a concurrent oral antidepressant.

Yes, starting with the 2025-2026 flu season, the FDA-approved FluMist® can be self-administered by eligible individuals or administered by a caregiver.

No, Opvee (nalmefene) is a prescription nasal spray approved in May 2023 for opioid overdose reversal. Other naloxone nasal sprays, like Narcan and RiVive, are available over-the-counter.

Neffy is a needle-free nasal spray alternative to the injectable EpiPen, with clinical trials showing similar blood concentration levels and physiological effects for treating anaphylaxis.

Common side effects of Neffy include throat irritation, tingling nose, headache, and nasal discomfort. Some patients may also experience jitteriness or nausea.