Acne Vulgaris Overview

  • Acne is a disease of the pilosebaceous unit involving increased sebum production, bacterial proliferation and inflammation1
  • 40 to 50 million people in the US have acne including approximately 10 million with moderate to severe acne
  • Acne commonly occurs in adolescents and in patients between 15 to 24 years of age with prevalence of approximately 85%
  • The US spend on acne prescription drugs is estimated to reach $7 billion by 20252
  • Current treatments like benzoyl peroxide, retinoids (e.g., isotretinoin) or antibiotics (e.g., clindamycin) are suboptimal due to side effects and/or limited efficacy
  • Moderate to severe acne is widely treated with oral therapies
  • Isotretinoin is teratogenic and associated with multiple clinical side effect, psychiatric disorders and biochemical changes3. It is sold in the US only under REMS program*
  • A well tolerated oral drug, which can effectively reduce sebum production could become an attractive therapeutic alternative to Isotretinoin

  • 1 Journal of Investigative Dermatology (2006) 126, 2154–2156
  • 2 Cowen March 2019
  • 3 Accutane FDA label
  • * FDA mandated “restricted-distribution risk evaluation and mitigation strategy