VecticalOintment 3mcg/g vitamin D3 treatment

Approval Date

January 23,2009


Release Date

Q1 of 2009






Vitamin D3Ointment



For thetreatment of mild-to-moderate plaque psoriasis in adults.


Active Ingredient



Agency Roster

Sudler and Hennessey


Marketing Strategy/Execution

Vectical Ointment 3 mcg/g is the only topical vitamin D3 ointmentof its kind now available in the United States for treating mild-to-moderateplaque psoriasis in adults 18 years and older.  The ointment fulfills animportant unmet need for patients who do not have access to an ointment thatcan help manage their condition both safely and effectively over thelong-term.  Though other vitamin D-based topical therapies are available,Vectical Ointment is the only to use the naturally-occurring, active form ofvitamin D3, and is one of the only Vitamin D3 products shown in clinical trialsto be well-tolerated even when used in sensitive skin fold areas. Galderma plans to promote these treatments to a variety of audiences.


Physician Outlook

Galderma’sVectical (calcitriol) is a novel vitamin D3 ointment for thetreatment of mild to moderate plaque psoriasis, with a naturallyoccurring, active form of Vitamin D3. Vectical’s demonstrated safetyand tolerability over 52 weeks of treatment will likely appeal todermatologists, who are eager for effective and tolerable agents for chronicdisease management.


– MaryMcBride, Associate Vice President, GfK Healthcare


Also in the Pipeline (courtesy ofAdis R&D Insight)

Drug: ABT-874

Manufacturer: CambridgeAntibody Technology / Abbott GmbH & Co. KG

Indication:Plaque psoriasis

Active ingredient: ABT-874

Phase: III


Drug: ABT-874

Manufacturer: CambridgeAntibody Technology / Abbott GmbH & Co. KG

Indication:Plaque psoriasis

Active ingredient: ABT-874

Phase: III


Drug: EnbrelÂ

Manufacturer: Amgen / Takeda

Indication:Ankylosing spondylitis

Active ingredient: Etanercept

Phase: Launched


Drug: Anti-IL-12/23p40 monoclonal antibody

Manufacturer: Centocor / Janssen-Cilag

Indication:Plaque psoriasis

Active ingredient: Ustekinumab

Phase: Launched

Source: Wolters Kluwer Health



Psoriasisis an autoimmune skin disorder that causes acceleration of the skin cell growthcycle. It affects 2 to 3 percent of the U.S. population. Plaque psoriasispresents as dry, red, scaly patches or lesions that are covered with dead skincells which give off a silvery-white appearance.


VecticalOintment contains calcitriol, the naturally-occurring, active form of vitamin D3.Its mechanism of action in the treatment of plaque psoriasis has not beenestablished.


Clinical Trials

Two 8-week,multicenter, double-blind, vehicle-controlled studies were conducted toestablish the efficacy of Vectical Ointment. A total of 839 patients with mildor moderate plaque psoriasis were randomized to receive treatment with eitherVectical Ointment or vehicle ointment twice daily for 8 weeks. Treatmentsuccess was defined as “Clear or Minimal” (up to light red or pink coloration,surface dryness with some white coloration, and slight elevation above normalskin) with at least a 2-grade change from baseline. At the end of 8 weeks,23.4% and 20.5% of patients treated with Vectical Ointment, in Studies 1 and 2respectively, achieved clear or minimal disease and a 2-grade improvement as comparedto 14.4% and 6.6% of patients treated with vehicle ointment.


The safetyand effectiveness of Vectical Ointment in patients with erythrodermic,exfoliative, or pustular psoriasis have not been evaluated.


Incontrolled clinical trials with Vectical Ointment, among patients havinglaboratory monitoring, hypercalcemia was observed in 24% (18/74) of patientsexposed to the drug and in 16% (13/79) of patients exposed to vehicle. However,the increases in calcium and albumin-adjusted calcium levels were less than 10%above the upper limit of normal. If abberations in parameters of calciummetabolism occur, treatment should be discontinued until these parameters havenormalized. The effects of Vectical Ointment on calcium metabolism followingtreatment duration greater than 52 weeks have not been evaluated. Increasedabsorption may occur with occlusive use.


Adverse Reactions

Hypercalcemia,lab test and urine abnormalities, psoriasis, hypercalciuria, pruritus.



=18 years:Apply to affected areas of the body twice daily (AM & PM). The maximumweekly dose should not exceed 200g.



<18years: not recommended.



Discontinueif hypercalcemia occurs (until normocalcemia returns). Avoid applying to eyes,lips, or facial skin. Avoid excessive exposure to natural or artificial light(tanning booths, sun lamps). Consider limiting or avoiding use of phototherapy.Pregnancy (Cat.C). Nursing mothers.



Cautionwith concomitant use of medications known to increase serum calcium (eg,thiazide diuretics), calcium supplements or high doses of vitamin D.