New Drugs and Therapies in 2022: Acne, Rosacea, and Pruritus

Continued research has led to several exciting therapeutic developments in drug delivery technologies as well as new and experimental medications for a wide spectrum of dermatological diseases and conditions including acne, rosacea, and pruritus.

In his presentation at the 2022 Maui Derm for Dermatologists meeting, Neal Bhatia, MD, director of clinical dermatology, at Therapeutics Clinical Research in San Diego, California, urged dermatologists not to be afraid of innovation. Instead, he called on them to be aggressive in learning about new treatments and putting these novel therapies and treatment modalities into daily practice, some of which may become first-line therapies.¹

Acne and Rosacea Benefit from Drug Delivery Advances

New drug delivery technologies have given rise to the development of novel formulations of medications that have shown to be helpful in an increasing number of dermatological diseases and conditions including acne, rosacea, and psoriasis.

FDA-approved in mid-2021, encapsulated products such as 5% encapsulated benzoyl peroxide (E-BPO) cream (Epsolay; Sol-Gel Technologies Ltd) and Twyneo (Sol-Gel Technologies Ltd), a combination of microencapsulated tretinoin 0.1% and microencapsulated BPO 3% cream, provided treatment options with enhanced tolerability thanks to their controlled release of encapsulated material, according to Bhatia. He added that this also resulted in more effective treatment outcomes.²

In December of 2021, Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd, announced the launch of an authorized generic of Epiduo Forte gel 0.3%/2.5%, another benzol peroxide-based treatment.³

“Twyneo for acne is probably going to replace some of the Epiduo Forte [adapalene and benzoyl peroxide, Galderma] presence since it is going generic. [Additionally,] adapalene [will be] available for rosacea soon as well. Twyneo may become a first-line treatment for acne given the demonstrated efficacy in the trials,” Bhatia said.

Molecule Stabilizing Technology (MST; Journey Pharmaceuticals) used in micronized minocycline in suspension mode has also been shown to improve treatment outcomes in patients with acne and rosacea by helping to optimize stability and efficient delivery of the active ingredient, he noted.

“Particle size reduction offers several advantages [in treating acne and rosacea) including improvement in contact between the active ingredient and the skin, increases in the number of particles to evenly cover the skin, penetration promotion through the stratum corneum, and enabling a smooth application,” Bhatia said.

Initially launched by VYNE Therapeutics, Amzeeq 4% is a topical formulation of minocycline FDA approved for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and children 9 years and older. Zilxi 1.5% is a topical minocycline for inflammatory lesions due to rosacea in adults. As of January 13, 2022, Journey Pharmaceuticals acquired the 2 products, along the MST technology.⁴

The unique physical foam characteristics in the composition, Bhatia said, include myristyl and stearyl alcohols, coconut oil and soybean oil, and low surfactants.

“Both of these medications have shown good efficacy and reduce the exposure to oral dose which involve higher concentrations in the plasma and more adverse events including an increased potential for antibiotic resistance,” Bhatia said.

Pruritus

Shown to work for itch independent of histamine, strontium is an ingredient that has been found to help mitigate itch in patients with moderate to severe pruritus, regardless of pathogenesis. It is thought to interfere with receptors and/or channels that rely on calcium. According to Bhatia, strontium works almost instantaneously upon application for up to 5 hours and can be useful for localized itching such as prurigo nodules or other cases with very focused itching.

“For many who have tried the new Dermeleve cream [Advanced Derm Solutions LLC], made with strontium, ceramides, and other ingredients that directly counter the impact of itch from C-nerve fibers and other contributing factors, the patient experience has been significantly positive as they describe the impact on quality of life. It is an OTC [over-the-counter] product and works really well for localized pruritus,” Bhatia said.

Other medications that have shown efficacy in improving itch include nalbuphine, an opioid receptor antagonist, and difelikefalin, an opioid receptor agonist that works well in patients with moderate to severe itching commonly seen in patients with kidney disease and other pruritic dermatoses, he added.

Disclosures:

Bhatia is an advisor and consultant investigator for with AbbVie, Almirall, Arcutis Biotherapeutics, Arena, Biofrontera, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant Sciences, EPI Health, Ferndale, Foamix, Galderma, Incyte, ISDIN, Johnson & Johnson, LaRoche-Posay, LEO Pharma, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, P&G, Regeneron Pharmaceuticals, Sanofi Pharmaceuticals, Stemline, Sun Pharma, and Vyne Therapeutics, and an investigator for Arcutis Biotherapeutics, Biofrontera, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant Sciences, Galderma, LEO Pharma, Eli Lilly and Company, and Ortho Dermatologics.

References:

1. Rosen T, Bhatia N. New drugs and therapies in 2022. Presented at: 2022 Maui Derm for Dermatologists; January 24 to 28, 2022; Maui, Hawaii.
2. Sol-Gel Technologies announces FDA approval of TWYNEO. Galderma. Press release. Published July 27, 2021. Accessed January 21, 2022. https://www.galderma.com/us/news/sol-gel-technologies-announces-fda-approval-twyneor
3. Teva announces launch of an authorized generic of Epiduo forte gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the U.S. Teva Pharmaceuticals. Press release. Published December 1, 2021. Accessed January 21, 2022. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-launch-of-an-authorized-generic-of-epiduo-forte-gel-adapalene-and-benzoyl-peroxide-gel-0/
4. Journey Medical Corporation acquires two FDA-approved topical minocycline products and molecule stabilizing technology (MST) franchise from VYNE Therapeutics, Inc. Journey Medical Corporation. Press release. Published January 13, 2022. Accessed January 21, 2022. https://www.globenewswire.com/news-release/2022/01/13/2366289/0/en/Journey-Medical-Corporation-Acquires-Two-FDA-Approved-Topical-Minocycline-Products-and-Molecule-Stabilizing-Technology-MST-Franchise-from-VYNE-Therapeutics-Inc.html