Newly Approved Oral Therapy: Sarecycline and Micronized Isotretinoin

EP: 1.Acne: Who, What, and When?

EP: 2.Prevalence of Acne in Adult Females

EP: 3.Impact of Acne Vulgaris on Quality of Life

EP: 4.Contributory and Predisposing Factors Influencing Acne

EP: 5.Clinical Manifestation and Differential Diagnosis of Acne

EP: 6.Common Sequelae and Potential Complications of Acne

EP: 7.Selecting Treatment Based on Pathophysiology of Acne

EP: 8.Newly Approved Topical Therapy: Clascoterone Cream 1% and Micronized Tretinoin 0.05% Lotion

EP: 9.Newly Approved Topical Therapy: Trifarotene 0.005% Cream, Tazarotene 0.045% Lotion, and Minocycline 4% Foam

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EP: 10.Newly Approved Oral Therapy: Sarecycline and Micronized Isotretinoin

EP: 11.Unmet Needs and Future Direction of Acne

Hilary E. Baldwin, MD: Another thing that certainly helps with compliance is the frequency of dosing. Jim, can you tell us about the new oral antibiotic, sarecycline? This is our first new-molecule antibiotic for the treatment of acne since 1971.

James Q. Del Rosso, DO: Sarecycline, as you know, is in the tetracycline class. It’s called a third-generation. We had doxycycline and minocycline as second-generation tetracyclines, which other than a few exceptions, were indicated for the treatment of infections. These were the various gram-positive infections, gram-negative infections, and other types of organisms. They were grandfathered in for the adjunctive treatment for severe acne, but that was not based on formal phase 2 and phase 3 clinical trials. They’ve been around a long time, and they’ve certainly been helpful to us and continue to be helpful to us, but they are broad spectrum in terms of their antibiotic activity.

Fast-forward to sarecycline, which we’ve had since 2018. Sarecycline has some structure activity changes that alter its antibiotic profile. It has a narrow spectrum, defined in this case as being active against C acnes [Cutibacterium acnes]. This year the FDA allowed the company, after it provided more information, to put something in the package insert about its activity against what it calls Propionibacterium acnes. It’s the same organism, and they made a statement in vitro that it has a low potential for resistance in spontaneous mutation strains of resistant organisms. They make that statement. It also has activity against staphylococci and streptococci and even methicillin-resistant strains of staphylococci, but it has not been evaluated and approved for that. It’s been FDA approved only for the treatment of acne. It has negligible activity against gram-negative organisms and several anaerobes.

When we’re utilizing an antibiotic, in this case a weight-based dosage once a day, down to the age of 9, it is shown to be effective for the face with some secondary evaluation also effective for acne vulgaris on the trunk, primarily for inflammatory lesions. We’re not trying to reduce organisms in the gut or in other microbiomes. Where we’re targeting the skin, we have less selection pressure against gram-negatives in the gut, for example. That’s believed to be an advantage: You’re going to have less selection pressure and fewer of the typical tetracycline-associated adverse effects that we’ve sometimes seen with the others. It’s not always that often, but they can certainly become associated. With things like vertigo, we didn’t see any vertigo, or room spinning, as we sometimes see with minocycline. It did not happen with sarecycline. Photosensitivity was also very low. GI [gastrointestinal] adverse effects like nausea, vomiting, abdominal pain, and esophagitis were also low. Vulvovaginal candidiasis was low. Yes, they can happen, but it’s low. There weren’t head-to-head studies, but if we look at comparative rates, there’s a low risk of those adverse effects. You have the antibiotic with less antibiotic resistance advantage, you have the low adverse-effect profile advantage, and you have approval down to age 9.

Hilary E. Baldwin, MD: When we’re talking about micronization as we have with many of the medications that we just mentioned, we can’t leave out the newer formulation of isotretinoin with Lidose technology with micronized particles that increase the surface area so that the medication is more bioavailable. Studies have shown that with this particular medication, the bioavailability is 50% higher than with the nonmicronized formulation of the Lidose technology isotretinoin, which in turn was already giving you better bioavailability on an empty stomach than conventional generic isotretinoin was giving. The implication is that, because the bioavailability is so good, you would be able to dose it on an empty stomach, as opposed to dosing it on top of a 50-gram fat meal, which of course makes obesity the No. 1 adverse effect of isotretinoin. This also gives our patients a choice, and we’re not giving them any kind of rules. As we said before, when you give a teenage patient rules, the chance of them not complying with their medication regimen is increased. Here is another situation of see drug, take drug.