Pharmacy & Therapeutics - October 2008 - (Page PP15)

PRODUCT PROFILER: Granisetron Transdermal Delivery System granisetron patches for the induction phase were considered better than or equivalent to the placebo patch. The two patches were considered to be slightly irritating (0.25 > MCI ≤ 1.00).15 During the induction phase, the investigator assessed patch adhesion three times a week in order to validate irritation assessments. Patches were reinforced with adhesive dressings where appropriate to ensure compliance. Results are summarized in Table 8 (see page 16).15 Subjective comments reported during the induction phase are presented in Table 9 (see page 16). Pruritus was the most frequently reported subjective symptom. The frequency of pruritus decreased slightly during the induction phase and was comparable between the two treatment groups.15 During the challenge phase, 200 subjects were analyzed for sensitization potential. One positive sensitization reaction (0.5%) was observed with the active granisetron patch when the patches were applied to the subject’s back. This subject did not agree to be rechallenged. A positive diagnosis of allergic contact reaction to the granisetron patch was based on the coexistence of: • a skin reaction with a score of 3 (erythema with individual vesicles). • delayed marked pruritus (no score, reported after the Day 3 assessment). • extension of the reaction beyond the patch test site (on the skin area where no test product was applied). • the kinetics of the skin reaction. No sensitization reactions were observed with the placebo patch.15 The investigator stopped applying patches in five subjects because of serious irritant reactions at the original patch site. Other skin reactions included a modification of skin pigmentation, which was ob served during the follow-up on the patch test sites in 26 subjects with either the active or placebo patch. The investigator judged this change to be a result of adhesive stripping of tanned skin.15 A total of 580 AEs were reported during the entire (%) Induction phase — Dermal response — Day 8 100 90 Granisetron 80 70 Placebo 60 50 40 30 20 10 0 No Slight Moderate Severe Erythema reaction erythema erythema erythema with vesicles (%) Induction phase — Dermal response — Day 15 100 90 Granisetron 80 70 Placebo 60 50 40 30 20 10 0 No Slight Moderate Severe Erythema reaction erythema erythema erythema with vesicles (%) Induction phase — Dermal response — Day 22 100 90 Granisetron 80 70 Placebo 60 50 40 30 20 10 0 No Slight Moderate Severe Erythema reaction erythema erythema erythema with vesicles Figure 5 Induction phase: frequency of irritation scores at each time point. (From Study 392MD/26/C, p 42.15) Table 6 Incidence of Skin Irritation during the Induction Phase No. (%) Granisetron Transdermal Delivery System Placebo From Study 392MD/26/C, p 43. 15 Day 8 27 (13.43) 45 (22.39) Day 15 12 (5.97) 24 (11.94) Day 22 13 (6.47) 32 (15.92) 15

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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