VTAMA A NEW FDA APPROVED DRUG.

1. VTAMA
PRESENTED BY-
VARSHA R WADNERE
Vth YEAR PHARM D
DOP- 24-08-2022

2. TABLE OF CONTENTS
1. Introduction
2. FDA approval
3. Description
4. Chemistry
5. Mechanism of action
6. Dose and administration
7. Dosage and strength
8. Pharmacokinetics
9. Pharmacodynamics
10. Special population
11. Adverse effects
12. Contraindications
13. Storage and handling
14. Cost of the drug
15. References

3. INTRODUCTION
➢VTAMA cream is a prescription medicine used on the skin (topical) to treat plaque psoriasis in
adults.
➢It is the first unique topical medication to be launched for psoriasis in 25 years, according to a
statement by Dermavant, Vtama's manufacturer.
➢The aryl hydrocarbon receptor (AhR) is a ligand-activated transcription factor that integrates
environmental, dietary, microbial and metabolic cues to control complex transcriptional
programmes in a ligand-specific, cell-type-specific manner.
➢Plays an important tumor-specific role in enhancing or inhibiting carcinogenesis, manages
immune system.

4. FDAAPPROVAL
➢VTAMA was granted FDA approval on 23-05-2022

5. DESCRIPTION
➢Generic Name- Tapinarof
➢Pharmacological Class- Aryl hydrocarbon receptor {AhR} agonist.
➢VTAMA cream also contains the following inactive ingredients:
benzoic acid, butylated hydroxytoluene {antioxidant}, citric acid monohydrate, diethylene glycol
monoethyl ether, edetate disodium, emulsifying wax, medium-chain triglycerides, polyoxyl 2 stearyl
ether, polyoxyl 20 stearyl ether, polysorbate 80, propylene glycol, purified water, and sodium citrate
dihydrate.

6. CHEMISTRY
➢Tapinarof is a white to pale brown powder.
➢Chemically, tapinarof is 3, 5-dihydroxy-4-isopropyl-transstilbene.
➢Also known as (E)-2-isopropyl-5-styrylbenzene-1,3-diol, with the empirical formula C17H18O2,
a molecular weight of 254.32, and the following structural formula.

7. MECHANISM OF ACTION
➢Tapinarof is an aryl hydrocarbon receptor (AhR) agonist.
➢The specific mechanisms by which VTAMA cream exerts its therapeutic action in psoriasis
patients are unknown.
➢The efficacy of tapinarof in psoriasis is attributed to its specific binding and activation of AhR, a
ligand-dependent transcription factor, leading to the downregulation of proinflammatory
cytokines, including interleukin 17, and regulation of skin barrier protein expression to promote
skin barrier normalization.

8. DOSE AND ADMINISTRATION
➢Apply a thin layer of VTAMA cream to affected areas once daily.
➢VTAMA cream is not for oral, ophthalmic, or intravaginal use.

9. DOSAGE AND STRENGTH
➢Cream, 1%
➢Each gram of VTAMA cream contains 10 mg of tapinarof.

10. PHARMACOKINETICS
➢Absorption
No accumulation was observed with repeat topical application.
Plasma concentration of tapinarof was below the quantifiable limits (BQL) of the assay (lower limit
of quantification was 50 pg/mL) in 68% of the pharmacokinetic samples.

11. ➢Distribution
Human plasma protein binding of tapinarof is approximately 99% in vitro.
➢Elimination
Metabolism
Tapinarof is metabolized in the liver by multiple pathways including oxidation, glucuronidation,
and sulfation in vitro.

12. PHARMACODYNAMICS
➢Pharmacodynamics of VTAMA cream are unknown.

13. SPECIAL POPULATION
➢Pediatric Use
The safety and effectiveness of VTAMA have not been established in pediatric patients.
➢Geriatric Use
No overall differences in efficacy, safety, or tolerability were observed between elderly subjects and
younger adult subjects in clinical trials.

14. ADVERSE EFFECTS
➢Folliculitis
➢Nasopharyngitis
➢Contact dermatitis
➢Headache
➢Pruritus
➢Influenza
➢Two (0.3%) subjects using VTAMA cream developed urticaria.

15. CONTRAINDICATIONS
➢ NONE.

16. STORAGE AND HANDLING
How supplied-
VTAMA (tapinarof) cream, 1% is a white to off-white cream. Each gram of VTAMA cream
contains 10 mg of tapinarof.
It is supplied in the following size: 60 g laminated tubes
➢Store at 20°C to 25°C (68°F to 77°F).
➢Do not freeze.
➢Protect from exposure to excessive heat.
➢Keep out of reach of children.

17. COST OF THE DRUG
➢ The cost for Vtama topical cream 1% is around $1,405 for a supply of 60 grams (1,12,219 INR).

18. REFERENCES
➢https://www.fda.gov/
➢https://www.pubmed.com/