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Atopic Dermatitis Provider Toolkit

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An 81-year-old woman is hospitalizedwith localized nonradiating low backpain of 3 weeks’ duration. She has nohistory of trauma, weakness of the legs,or urinary or bowel incontinence.

Octogenarian With Low Back Pain and an Enlarged Skull

A 67-year-old woman noted the appearance of several non-tender, rock-hard, purple-colored nodules on her legs. Her medical history was significant for distant non-Hodgkin lymphoma.

A 67-year-old woman noted the appearance of several non-tender, rock-hard, purple-colored nodules on her legs. Her medical history was significant for distant non-Hodgkin lymphoma. The violaceous color and configuration of the skin lesions suggests which of the following? 

Clinical Topics

Hard Purple Nodules: Your Dx?

A 76-year-old woman seeks your attention for an asymptomatic “red spot” on her neck. She has a history of multiple non-melanoma skin cancers.

Squamous cell carcinoma in situ (Bowen  disease)

Lichenoid keratosis (an inflammatory variant of seborrheic keratosis)

A 76-year-old woman seeks your attention for an asymptomatic “red spot” on her neck. What does this look like to you?

What's This "Red Spot"?

A 9-year-old boy presented with a 1-week history of pruritus and rash on his elbows, knees, back, and legs. Several areas of excoriation were noted. He had recently run through a field of tall grass but denied any other exposure history.

A 9-year-old boy presented with a 1-week history of pruritus and rash on his elbows, knees, back, and legs. He had recently run through a field of tall grass but denied any other exposure history. Your Dx?

What Cause of This Itchy Rash?

A 3-year-old boy is seen for unilateral swelling on the left side of the face, in front of and behind the left ear. Findings on examination of ears, oral cavity, and teeth are normal. He is afebrile (temp, 37°C [98.6°F]), cooperative, and in no distress. He is otherwise healthy. Past medical history includes 1 MMR vaccination.

The child is bright and alert and has no fever. The swelling is on the left side of the face only. Find other clues to a diagnosis in the accompanying video.  

3-Year-Old Boy With Unilateral Facial Swelling 

This image of the posterior neck of a 26-year-old woman shows a warty type fungating  lesion about the size of a quarter. It had been present since birth. It had been excised and treated with electrodessication several times previously but had always recurred. She had acute and chronic anxiety and would pick at the lesion.

The lesion was elliptically excised under local anesthesia in the office.

This lesion on the posterior neck of a young woman was present since birth and recurred after electrodessication. Can you Dx? 

A Warty, Fungating Lesion 

Educate physicians on the approved labeling and intended usage of 

Highlight the clinical efficacy through the presentation of data on the effectiveness of 

Outline ideal patient segments in the pediatric and adult patient populations aligned to the FDA approved labeling

Showcase the applicability and importance of the approval based on current treatment options and unmet needs

 (epinephrine nasal spray) is an α- and β-adrenergic receptor agonist indicated for emergency treatment of type-1 allergic reactions including anaphylaxis in adult and pediatric patients who weigh 30 kg or greater.

 Neffy is the first and only FDA-approved needle-free option for administering epinephrine, which is its active ingredient.

 Epinephrine has been used to treat allergic reactions for more than 100 years, and it currently is the only universally recommended first-line treatment for severe allergic reactions such as anaphylaxis, which can include symptoms such as difficulty breathing, hives, tachycardia, confusion, diarrhea, stomach cramps, dizziness, or unconsciousness.

 It is imperative to initiate treatment with epinephrine at the first sign or symptom of a severe allergic reaction to halt its progression, particularly when the course of the reaction is unpredictable and may initially present as mild.

Epinephrine is most frequently administered via an epinephrine autoinjector (EAI).

 However, there are several barriers to immediate EAI use including high costs, fear of needles, unwillingness to carry the EAI, and lack of proper training. Users report that EAIs are cumbersome and inconvenient, and up to 83% of patients and caregivers either fail to use or delay in using an EAI at the time of a severe allergic reaction.

 Failed or delayed treatment may lead to a higher risk of severe anaphylaxis, biphasic reactions, hospitalization, and death.

As a needle-free epinephrine nasal spray, neffy may offer clinical benefit by addressing the apprehension and delay associated with use of EAIs, reducing the risk of accidental injection, and improving the ease of carrying the product.

 This article provides an overview of neffy including product characteristics, mechanism of action, efficacy and safety data, and dosage and administration.

NEFFY® is available as a single-dose nasal spray with 0.1 mL solution that is comprised of 3 FDA-approved ingredients and components: 2 mg epinephrine, which is the active ingredient; Intravail

 (dodecylmaltoside), a proprietary agent that helps enhance the bioavailability of intranasal drugs; and a unit dose spray (UDS) that produces a spray pattern and droplet size that optimizes delivery of the spray to the turbinate.

According to clinical guidelines and global agreement, epinephrine is considered the most effective treatment for anaphylaxis.

 Epinephrine acts on 1) α-adrenergic receptors, which in turn decrease the vasodilation and vascular permeability that is associated with anaphylaxis, and 2) β-adrenergic receptors, which relax bronchial smooth muscles and reduce bronchospasm, wheezing, and dyspnea that can occur with anaphylaxis. In addition, epinephrine may relieve pruritus, urticaria, and angioedema. Because it can relax the smooth muscle of the stomach, intestine, uterus, and urinary bladder, the compound may also alleviate gastrointestinal and genitourinary symptoms.

Intravail is an alkylsaccharide that enhances epinephrine absorption by changing mucosal viscosity and membrane fluidity, thereby loosening cell-to-cell junctions. It is water- and oil-soluble and does not irritate or harm mucosal membranes.

 With Intravail, the absorption of epinephrine does not appear to be affected by epinephrine’s vasoconstrictive effects, which enables the epinephrine dose to be as low as possible while maintaining efficacy. A low dose of epinephrine offers safety advantages: It minimizes the risk of epinephrine overdose, which has been reported with use of EAIs and manual intramuscular (IM) injection; and it lowers the risk of adverse events (AEs), such as abdominal pain, nausea, and vomiting.

The UDS of neffy has been used for several other intranasal medications for more than 20 years. Offering ease of use, the UDS is associated with a failure rate of less than 1 in 100,000 uses; it supplies more than 80% of the epinephrine in droplets that are between 20 and 120 µm in size. Nearly all of the droplets released from the UDS are caught on the nasal turbinates.

Due to inherent barriers that negate the ability to conduct prospective trials with patients who are experiencing anaphylaxis, the development strategy for neffy involved determining that its pharmacokinetic (PK) profile was in range with those of currently approved manual IM injections and EAIs.

 For approval of neffy, the FDA required that minimum exposures must be greater than or equal to that of epinephrine 0.3 mg IM injection or subcutaneous (SC) administration (as an efficacy measure), and maximum exposures must be less than that of EpiPen

 Throughout studies, pharmacodynamic (PD) data also served an important role in determining the efficacy profile.

Currently approved epinephrine injection products include epipen 3 mg, Auvi-Q

 0.3 mg epinephrine 0.3 mg IM injection, and epinephrine 0.3 mg SQ. Their efficacy rate is 90% as a single dose, although their individual PK profiles vary widely.

PatientCare Launch Lens: A look at NEFFY® (epinephrine nasal spray)

Murthy Gedala, MD

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