Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004 1 Clinical Wrap-Up Denise Cook, M.D. Medical Officer Division of Dermatology and Dental.

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Presentation transcript:

Dermatologic and Ophthalmic Drugs Advisory Committee July 12, Clinical Wrap-Up Denise Cook, M.D. Medical Officer Division of Dermatology and Dental Drug Products Denise Cook, M.D. Medical Officer Division of Dermatology and Dental Drug Products

Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 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 Drug use trends of topical tazarotene Adverse events with topical tazarotene Efficacy of topical tazarotene Efficacy of oral tazarotene

Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 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 1 IMS Health, National Prescription Audit Plus , Data Extracted June IMS Health, National Disease and Therapeutic Index , 6 yr CD-Rom, Jan 1998 – Dec 2003 Extracted 6/2004 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 1 IMS Health, National Prescription Audit Plus , Data Extracted June IMS Health, National Disease and Therapeutic Index , 6 yr CD-Rom, Jan 1998 – Dec 2003 Extracted 6/2004

Dermatologic and Ophthalmic Drugs Advisory Committee July 12, % of all dispensing to women % of all claims for women of childbearing age (12-44 years) 1 1 AdvancePCS  Dimension Rx, Data Extracted June % of all dispensing to women % of all claims for women of childbearing age (12-44 years) 1 1 AdvancePCS  Dimension Rx, Data Extracted June 2004 Drug Use Trends for Topical Tazarotene Year 2003

Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 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)

Dermatologic and Ophthalmic Drugs Advisory Committee July 12, Worldwide Pregnancy Exposures Associated with Topical Tazarotene ** 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

Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 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% 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%