Clinical Wrap-Up

1
Clinical Wrap-Up

• Denise Cook, M.D.
• Medical Officer
• Division of Dermatology and Dental Drug Products

2
Other Information on the Safety and Efficacy of
the Chemical Moiety

• Drug use trends of topical tazarotene
• Adverse events with topical tazarotene
• Efficacy of topical tazarotene
• Efficacy of oral tazarotene

3
Drug Use Trends for Topical Tazarotene

• Total number of tazarotene (Tazorac, Avage)
  prescriptions dispensed increasing
• 226,000 (1999)
• 937,000 (2003)1
• In 2003, most commonly prescribed by
• dermatologists (67)
• family practitioners (7)1
• In 2003, most common diagnoses associated with
  use
• acne (75)
• psoriasis (13)2

4
Drug Use Trends for Topical TazaroteneYear 2003

• 58 of all dispensing to women1
• 46.5 of all claims for women of childbearing age
  (12-44 years)1
• 1AdvancePCS? Dimension Rx, Data Extracted June
  2004

5
125 AERS Reports Associated with Topical
Tazarotene (June 1997 to May 24, 2004)
Most Common AEs Pruritus, rash erythematous, dermatitis exfoliative, burning sensation, drug ineffective, erythema
Systemic AEs Liver enzyme elevation (3), gastrointestinal (3), hot flashes and perspiration (1), ? triglycerides (1)
Indications for Use Psoriasis (91), Acne (8), Other Skin (10), NR (16)
Gender Female (69), Male (52), NR (4)
Serious Outcomes Hospitalizations (2), Congenital Anomaly (1)
6
113 Worldwide Pregnancy Exposures Associated with
Topical Tazarotene
US 107, Foreign 6 US 107, Foreign 6
Age Range 17 to 38 years, median 29 years, n 24
Indications for topical tazarotene Acne (60) Psoriasis (20) Facial Wrinkling (2) Other (5), NR (26)
Pregnancy and Fetal Outcomes Spontaneous Abortion (4) Chromosomal Abnormalities (2) Trisomy 18, Cornelia de Lange No adverse outcome or Unknown (107)
Data Obtained from Sponsor December 4, 1996 to
May 15, 2004
7
Efficacy of the Chemical Moiety in the Treatment
of Plaque Psoriasis

• Topical Tazarotene
• Clinical Trials Success 75 improvement
• 0.05 gel
• 30 and 18
• 0.1 gel
• 38 and 25
• Placebo
• 13 and 10
• Oral Tazarotene
• Clinical Trials Success no or minimum disease
• 15.2 and 18.7
• Placebo 1.2 and 4.8
• Clinical Trials - 2 efficacy parameter Success
  75 improvement (or marked improvement or
  better)
• 30.1 and 30.8
• Placebo 8.2 and 9.1