Pulmonary-Allergy Drugs Advisory Committee. NDA 21-395 Spiriva ® (tiotropium bromide) Inhalation Powder Eugene J. Sullivan, MD FCCP Medical Officer Division of Pulmonary and Allergy Drug Products. Outline. Background PK/PD characteristics Overview of P3 clinical program
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Pulmonary-Allergy Drugs Advisory Committee
Spiriva® (tiotropium bromide)
Eugene J. Sullivan, MD FCCP
Division of Pulmonary and Allergy Drug Products
“treatment of bronchospasm
and dyspnea associated with COPD”
Phase 3, one-year, placebo-controlled studies:
Phase 2 Study:
Chest Pain 5.3%2.2%
Dry Mouth 12.1%6.1%
TDI “responders” at 6 months
130 42%** 26% 35%
137 45%* 33% 48%**
*p<0.05 (placebo comparison)
**p<0.01 (placebo comparison)
[Responders defined as patients with TDI score 1]
Number Needed to Treat (NNT) Analyses*
*To achieve one “responder,” defined as TDI 1
TDI “responders” at 8 and 16 weeks
130 40%* 24% 34%
137 44%* 31% 47%**
130 43%* 27% 34%
137 42%* 30% 47%**
* p<0.05 (placebo comparison) **p<0.01 (placebo comparison)
1. Is the safety database for tiotropium bromide inhalation powder for the treatment of COPD patients adequate?
A) If not, what further safety data should be obtained?
B) Which of the safety data should be obtained prior to approval?
2. Are there specific safety concerns regarding the use of tiotropium bromide inhalation powder in the COPD patient population that merit specific attention in the product label?
3. Do the data provide substantial and convincing evidence that tiotropium bromide inhalation powder provides a clinically meaningful bronchodilator effect when used in the chronic treatment of patients with COPD?
4. Do the data provide substantial and convincing evidence that tiotropium bromide inhalation powder provides a clinically meaningful effect for the symptom of dyspnea in patients with COPD?
5. In general, what quality and quantity of data would constitute substantial and convincing evidence of a clinically meaningful benefit for the symptom of dyspnea in patients with COPD?