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New Drugs Tackle Tough Challenges


Potential game-changers in the pipeline and newly FDA-approved treatments were highlighted in an overview of new drugs to watch at Maui Derm NP+PA Fall 2021 meeting.

A robust pipeline and a wave of newly FDA-approved drugs are dramatically expanding the armamentarium for dermatology. Ted Rosen, MD, provided a detailed walkthrough of the promising new drugs in his presentation at Maui Derm NP+PA Fall 2021 held September 30 to October 2, 2021, live in Asheville, North Carolina, and virtually.1

“It’s an exciting time to be in dermatology,” said Rosen, chief of dermatology, Michael E. DeBakey VA Medical Center, professor of dermatology at the Baylor College of Medicine at Baylor University, both located in Houston, Texas. “There is nothing out there like the new agents in the pipeline for various diseases and disorders.”

Rosen outlined his list of the most-anticipated new drugs:


  • Microencapsulated benzoyl peroxide (BPO) cream (Epsolay, Sol-Gel Technologies) 5%
    • Phase 3
    • Endpoints: Clear/almost clear and 2-grade reduction 43.5/5.0 versus 16.1/125.9% for vehicle.2


  • Microencapsulated BPO 3% cream and microencapsulated tretinoin 0.1% (Twyneo, Sol-Gel Technologies)
    • FDA approved
    • First FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide.

Pediculosis Capitis

  • Abametapir 0.74% lotion (Xeglyze, Dr. Reddy’s Laboratories)
    • FDA approved for patients from 6 months
    • Prevents egg from opening and interferes with vital enzymes in adult lice.
    • Application takes 10 minutes


  • Spinosad, both spinosyns (natural) and spinosoids (synthetic)
    • FDA approved
    • Potent insecticide but has no activity against mammals and avian and aquatic animals.
    • Single application (6 to 8 hours)
  • Lonafarnib (Zokinvy, Eiger BioPharmaceuticals Inc)
    • FDA approved
    • Interferes with progerin synthesis while improving cellular replication and fibroblast function.
    • Most expensive US drug: $86,000 a month, according to Rosen.
    • Rosen cautioned about serious side effects but provided perspective that this drug can extend the patient’s lifespan beyond their teens.

Actinic Keratosis (AK)

  • Tiranibulin (Klisyri, Amirall)
    • FDA approved
    • Anti-proliferative and anti-tumor activity
    • Inhibits in vitro tubulin polymerization while promoting microtubule disruption as well as Src kinase signaling in various cancer cells.
    • Does not cause pronounced release of inflammatory cytokines.


  1. Rosen T. New Drugs and Drug Therapies for 2021. Presented at Maui Derm NP+PA Fall 2021; September 30 to October 2, 2021; live in Asheville, North Carolina, and virtual.
  2. Bhatia N, Werschler W, Baldwin H, et al. Long-term efficacy and safety of benzoyl peroxide cream, 5%, prepared with microencapsulation in papulopustular rosacea: results from an extension of two phase 3, vehicle-controlled trials. Poster presented at: Maui Derm Live In-Person Dermatology CME Conference and Maui Derm Connect Virtual Dermatology CME Conference; January 25-29, 2021; Maui, Hawaii; Virtual.
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