adquey
Adquey (Difamilast) is a medication used to treat Atopic Dermatitis.
Difamilast · by Acrotech Biopharma
Key facts
- Active ingredient
- Difamilast
- Form
- Topical
- Strength
- Difamilast 1%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- atopic dermatitis
- Manufacturer
- Acrotech Biopharma
- FDA application
- NDA219474
What is Adquey?
From the FDA label:ADQUEY (difamilast) ointment contains difamilast as the active ingredient. Difamilast, is a phosphodiesterase-4 (PDE-4) inhibitor. Difamilast is described chemically as N-({2-[4-(Difluoromethoxy)-3-(propan-2-yloxy)phenyl]-1,3-oxazol-4-yl}methyl)-2-ethoxybenzamide. The empirical formula is C 23 H 24 F 2 N 2 O 5 and the molecular weight is 446.44 g/mol. The structural formula is represented below: Difamilast occurs as white (or practically white) crystals or crystalline powder. It is very soluble in N-methylpyrrolidone, freely soluble in methanol and ethanol (99.5), and practically insoluble in water. It shows crystal polymorphism. Each gram of ADQUEY contains 1% difamilast (w/w) in a wax-based, white to off-white ointment containing the following inactive ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax. Structure
How to use
2 DOSAGE & ADMINISTRATION ADQUEY is for topical use only and not for ophthalmic, oral, or intravaginal use. Apply a thin layer of ADQUEY twice daily to affected areas and rub in completely. Wash hands after application. Avoid areas of the skin that are infected when applying ADQUEY. For topical use only. Not for ophthalmic, oral, or intravaginal use. (2) Apply a thin layer of ADQUEY twice daily to affected areas and rub in completely. (2)
Side effects
The most common adverse reaction occurring in ≥1% of subjects is nasopharyngitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc. at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ADQUEY was assessed in two double-blind, vehicle-controlled clinical trials (Trial 2 and Trial 3) that enrolled 532 adult and pediatric subjects 2 years of age and older in Japan with mild to moderate atopic dermatitis (AD). Subjects applied ADQUEY or vehicle ointment topically twice daily for 4 weeks [ see Clinical Studies (14) ]. Adverse reactions reported by ≥1% of ADQUEY-treated subjects and more frequently than in subjects receiving vehicle are listed in Table 1. Table 1: Adverse Reactions Occurring in ≥1% of Adult and Pediatric Subjects 2 Years of Age and Older Treated with ADQUEY for Mild to Moderate Atopic Dermatitis (and Greater than Vehicle) through Week 4 in Trials 2 and 3 Adverse Reaction ADQUEY (N=267) n (%) Vehicle (N=265) n (%) Nasopharyngitis 16(6) 10(4) Less common (<1%) adverse reactions in subjects treated with ADQUEY in Trials 2 and…
Who should not take Adquey
None. None. (4)
Storing Adquey, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store ADQUEY at room temperature between 68°F to 77°F (20°C to 25°C).”
- “Store ADQUEY away from direct sunlight, heat and moisture.”
May treat (source: NIH RxClass)
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Adquey treat?
- Adquey (Difamilast) may be used to treat atopic dermatitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Adquey?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Adquey. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Adquey?
- Adquey is marketed by Acrotech Biopharma. You can see Acrotech Biopharma's full profile, rating, and other products on pharmaranks.
- Is Adquey a brand-name or generic drug?
- Adquey is a brand-name product with the active ingredient Difamilast.
- Is Adquey available over the counter?
- No. Adquey is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Adquey come in?
- Adquey is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Adquey FDA-registered?
- Adquey is on record with the U.S. FDA under application number NDA219474. You can verify this on its official FDA label.
- Is Adquey safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Adquey. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Adquey?
- Adquey's side effects are taken directly from its FDA label. From the label: The most common adverse reaction occurring in ≥1% of subjects is nasopharyngitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc. at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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