What Does the FDA Approval of Roflumilast Mean for Patients with Seborrheic Dermatitis?

One of the most hotly anticipated US Food and Drug Administration’s (FDA) approvals in dermatology was that of roflumilast foam, 0.3%, for patients aged 9 years and older with seborrheic dermatitis.

This FDA approval marks the first approved drug for seborrheic dermatitis with a new mechanism of action in almost 20 years, and it is a milestone for patients in a large age bracket with the inflammatory skin condition. In fact, around 10 million Americans with the skin disease will now potentially have access to this drug.

Neal Bhatia, MD, the director of clinical dermatology at Therapeutics Clinical Research and the chief medical editor for Practical Dermatology, spoke with the HCPLive editorial team about this approval and what it could mean for so many patients with so few options for their condition.

“Thinking about what has been done in seborrheic dermatitis, it's basically been the disease where people have been throwing things to the wall hoping they stick,” Bhatia explained. “We've seen antifungal shampoos, primarily, a lot of over the counter steroids and over the counter topical antifungals. The biggest problem is the identification of the mechanism of the disease, and matching it to the mechanism of therapies, as well as thinking about the locations where seborrheic dermatitis occurs.”

Bhatia commented that by roflumilast slowing down the conversion of active cytokine production and propagation of itself, the drug may slow down the potential for the disease itself to flow. He also described some of the phase 3 STRATUM trial data that led to the approval itself.

“The nice news of it is that the study met a good endpoint with 80% of the individuals achieving what they called ‘clear or almost clear,’ which was fantastic for the study,” Bhatia said.

When discussing safety data, Bhatia also noted that among those who were on the active drug, less than 1% actually terminated treatment due to any adverse events.

“So without an end organ issue, without risk of steroid atrophy, without the issues of tachyphylaxis, I think we have a steady dose that's independent of age, gender, skin type, location,” Bhatia said. “And we also have the ability of the molecule to not involve any kind of visceral effects that would be dose-limiting. So I think from that standpoint, we have a lot of opportunities there when using it for the long run.”

Bhatia added that when he starts using this in the clinic, he will say ‘Here, treat for 2 months and if things are going well, take a break, start again, and keep going if you want to keep going and maintain things, especially if your things start to flare.’
“I would encourage everyone to take a sample, give it to the patient in the exam room, and have them try it out,” Bhatia said. “Have them see the versatility of the foam, have them try how easy it is to spread, how easy it is to go on the face and the scalp. Or behind the ears and the areas of the neck and chest perhaps where seborrheic dermatitis can also show up. Take their patients and give it a try. Because that's really the only way we're going to learn if those patients are right for that treatment in your own office.”

To learn more about the approval and data, view the full interview above.

The quotes contained here were edited for the purposes of clarity.