Enstilar (calcipotriene and betamethasone dipropionate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved October 2015

Specific Treatments:

psoriasis

Therapeutic Areas

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General Information

Enstilar is a dual-action investigational aerosol foam containing calcipotriol, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.

Enstilar is specifically indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

Enstilar is supplied as a foam for topical administration. It should be applied to affected areas once daily for up to 4 weeks, and rubbed in gently. Discontinue use when control is achieved. No more than 60 g every 4 days should be used.

Clinical Results

FDA Approval

The FDA approval of Enstilar was based on two multicenter, randomized, double-blind trials were conducted in subjects with plaque psoriasis. In Trial One, 302 subjects were randomized to 1 of 3 treatment groups: Enstilar Foam, betamethasone dipropionate in the same vehicle, or calcipotriene hydrate in the same vehicle. In Trial Two, 426 subjects were randomized to 1 of 2 treatment groups: Enstilar Foam or the vehicle alone. Baseline disease severity was graded using a 5-point Investigator’s Global Assessment (IGA). At baseline subjects scored “Mild”, “Moderate”, or “Severe”. The majority of subjects in both trials (76% and 75%) had disease of “Moderate” severity at baseline, 14% and 15% of subjects had disease of “Mild” severity at baseline and 10% of subjects had “Severe” disease at baseline in both trials. The extent of disease involvement assessed by mean body surface area was 7.1% (range 2 to 28%) and 7.5% (range 2 to 30%). In both trials, subjects were treated once daily for up to 4 weeks. Efficacy was assessed with treatment success defined as the proportion of subjects at Week 4 who were “Clear” or “Almost Clear” according to the IGA. The percentage of subjects achieving treatment success is as follows: Trial One: Enstilar Foam: 45% Betamethasone dipropionate: 30.7% and callcipotriene: 14.9%. Trial Two: Enstilar Foam: 53.3% and vehicle: 4.8%.

Side Effects

Adverse effects associated with the use of Enstilar may include, but are not limited to, the following:

  • application site irritation
  • application site pruritus
  • folliculitis
  • skin hypopigmentation
  • hypercalcemia
  • urticaria
  • exacerabation of psoriasis

Mechanism of Action

Enstilar is a dual-action investigational aerosol foam containing calcipotriol, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.

Additional Information

For additional information regarding Enstilar or plaque psoriasis, please visit http://enstilar.com/