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The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays

The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays. Vincent H.L. Lee, Ph.D., Chair Nancy Chamberlin, Pharm.D., Executive Secretary Orally Inhaled and Nasal Drug Products (OINDP) Subcommittee of Advisory Committee for Pharmaceutical Science Rockville, MD 17 July 2001.

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The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays

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  1. The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays Vincent H.L. Lee, Ph.D., Chair Nancy Chamberlin, Pharm.D., Executive Secretary Orally Inhaled and Nasal Drug Products (OINDP) Subcommittee of Advisory Committee for Pharmaceutical Science Rockville, MD 17 July 2001

  2. 1999 BE Recommendations Suspension Formulation Nasal Sprays and Nasal Aerosols • Q1(active/inactives) and Q2 (inactives) sameness • Device recommendations • Comparable in vitro performance • Comparable in vivo performance for systemic exposure or absorption • Comparable in vivo performance for local delivery

  3. QUESTION #1 Does the committee believe that a placebo-controlled traditional two-week rhinitis study conducted at the lowest active dose is sufficient to confirm equivalent local delivery of suspension formulation nasal sprays and nasal aerosols for allergic rhinitis?

  4. QUESTION #2 Does the committee believe that a placebo-controlled park study or an EEU study conducted at the lowest active dose is an acceptable option to confirm equivalent local delivery of suspension formulation nasal sprays and nasal aerosols for allergic rhinitis?

  5. V.H.L. Lee, Ph.D. G.L. Anderson, Ph.D. M.S. Dykewicz, M.D. R.C. Ahrens, M.D. L. Hendeles, Pharm.D. D.R. Ownby, M.D. W.W. Hauck, Ph.D. I.J. Roman, M.D., Ph.D. L. Shargel, Ph.D. E. Shek, Ph.D. H. Winkle R.J. Meyer, M.D. B. Chowdhury, M.D. W. Adams, Ph.D. D. Conner, Pharm.D. OINDP

  6. To establish BE of suspension formulation nasal aerosols and nasal sprays for allergic rhinitis The June 1999 draft guidance BA and BE Studies for Nasal Aerosols and Nasal Sprays for LocalActionrecommends equivalence offormulation, both qualitatively and quantitatively; device; in vitro studies; and systemic exposure or systemic absorption. The in vitro studies, however, do not assure equivalence of particle size of the suspended drug. Because particle size differences between test and reference products have the potential to alter the rate and extent of delivery of drug to local sites of action in the nose,differences in clinical effectiveness could result. For this reason, the draft guidance also recommends the conduct of a clinical study for allergic rhinitis to confirm equivalent local delivery.

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