Roflumilast Clinical Development Program in Plaque Psoriasis

Leon Kircik, MD: I’ve been lucky enough to get involved with the roflumilast studies from day 1. Of course, in order to get any drug approved in this country, we have to have the early studies, and then we have phase 2 and phase 2b, then the phase 3 study that gets the drug approved. Now the agency also requires an open label long-term extension, which is 1 year for topicals and 5 years for systemic treatments.

Roflumilast 0.3% cream has been approved already for plaque-type psoriasis in patients 12 years of age and older. Also, we are studying roflumilast 0.3% foam for scalp psoriasis, as well as body psoriasis, which I think is going to make life easier for our patients, applicationwise. In addition to that, the foam is also being studied for seborrheic dermatitis. Ironically, that’s one of the biggest unmet needs in dermatology. I don’t even remember when was the last time we did a clinical study for the seborrheic dermatitis indication. I think it was years ago. The only drug that we had approved by the agency for seborrheic dermatitis indication was ketoconazole foam and ketoconazole gel, and that was quite a few years ago, if I remember correctly.

Now, the other indication that we are studying for roflumilast is for atopic dermatitis. There it’s 0.1% concentration rather than the 0.3% concentration. However, I do want to touch one more point that I think is crucial here. In the psoriasis approval label we have information about intertriginous psoriasis indication. This is the only topical that I know of that we have labeled for intertriginous psoriasis. We did study that in the psoriasis studies. It’s a big unmet need because we are very concerned with overusing topical steroids in intertriginous areas. As you know, we’re not supposed to overuse because of the adverse event profile of topical steroids, especially in these areas where the skin is really thin and delicate. Having an unmet need in this area, and roflumilast finally addressing this as a new topical development, I think is a big improvement in our armamentarium for the treatment of intertriginous psoriasis.

Transcript edited for clarity