A closer look at new FDA actions: Galderma's Vectical

Dr. Holmberg is the pharmacy coordinator at Desert Vista Behavioral Health Center in Mesa, Arizona.

The FDA has approved Galderma’s Vectical (calcitriol) Ointment 3 mcg/g for the treatment of mild-to-moderate psoriasis in adult patients.¹ Vectical is a unique product that utilizes vitamin D₃ and is the only medication of its kind to be available in the United States. It is promoted as a better-tolerated agent for long-term treatment of psoriasis, and clinical trials have shown Vectical to be less irritating on sensitive areas, such as skin folds, than other forms of topical vitamin D₂ The exact mechanism of action of Vectical has not been identified.¹

Psoriasis is a chronic autoimmune disorder that affects the skin and is categorized into 5 types: plaque, guttate, inverse, pustular, and erythrodermic. The most common form of psoriasis is plaque, which presents as patches of raised red lesions covered with a silvery-white scale.² Although psoriasis may occur anywhere on the body, the most common places for it to appear are on the elbows, knees, scalp, umbilicus, and lumbar area.

The exact cause of psoriasis is currently unknown, but it is believed to have a genetic link.³ Psoriasis has no cure, and it is associated with comorbidities, including diabetes, heart disease, depression, and obesity.^2,4 It is estimated that up to 7.5 million individuals in the United States have psoriasis.²

Clinical Trials

Vectical was evaluated in 2 multicenter, double-blind, vehicle-controlled studies for a duration of 8 weeks. Patients were randomized to receive either twicedaily treatment with Vectical or with a vehicle ointment. Patients included in the trials had mild or moderate psoriasis as determined by an investigator global assessment scale; the baseline severity assessment was moderate for the majority of patients.

Successful treatment was considered to be clear-to-minimal disease at the end of the 8 weeks (up to light red or pink coloration; surface dryness with some white coloration; and slight elevation above normal skin level). In addition, patients must have displayed an improvement of at least 2 grade changes from their initial rating.

The first study included 209 patients in the Vectical arm and 209 patients in the vehicle arm. At the study’s end, 23.4% of patients in the Vectical group attained successful treatment, compared with 14.4% of patients in the vehicle group.

The second study included 210 patients in the Vectical arm and 211 patients in the vehicle arm. This study determined success rates to be 20.5% in the Vectical group and 6.6% in the vehicle group.¹

Dosage

Vectical should be applied only to the affected psoriatic plaques twice a day and gently rubbed into the area until it is no longer visible on the skin. Each gram of Vectical will provide 3 mcg of calcitriol. The total weekly dose should not exceed 200 g.¹

Warnings, Precautions, and Adverse Reactions

No contraindications are associated with the use of Vectical. Hypercalcemia was observed in patients using Vectical during clinical trials. If abnormal values occur, treatment with Vectical should be discontinued until levels normalize. Patients using Vectical should avoid excessive exposure to natural and artificial sunlight, as the vehicle of Vectical ointment may potentiate the effect of ultraviolet radiation to cause skin tumors.

Vectical is a Pregnancy Category C drug. Caution should be used during breast-feeding, as it is currently unknown if Vectical is excreted into human milk. Vectical is not indicated for use by patients under age 18.

Vectical is only intended for external application. It should not be applied to the eyes, lips, face, or vagina.

The most commonly reported adverse reactions are abnormal lab tests, urine abnormality, psoriasis, hypercalciuria, and pruritus.¹ â–