Nonallergic and Allergic Rhinitis: FDA Finalizes Guidance
Posted 05 September 2018 | By
The US Food and Drug Administration (FDA) on Wednesday finalized two guidance documents: one on developing treatments for nonallergic rhinitis (NAR) and one on developing allergic rhinitis treatments.
The guidance to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults, finalizing a draft from February 2016, addresses issues of trial design, effectiveness and safety for new products being developed for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).
In terms of changes between the draft and final, FDA said all the public comments received have been considered and the guidance has been revised “as appropriate along with a few editorial changes.”
The recommendations in the 16-page guidance are based on an assessment of important issues raised in the
review of both adult and pediatric allergic rhinitis clinical trials and FDA’s current understanding of the mechanism of the SAR and PAR.
“Despite different causes and temporal patterns of disease, the same groups of chemical mediators appear to be regulators of the responses in SAR and PAR. It is for this reason that distinctions between SAR and PAR in terms of clinical trial design are made only in clinically relevant areas,” the guidance says.
The other 9-page final guidance, also finalizing a draft from February 2016, “has been revised primarily to update references and to clarify,” according to FDA.
The guidance discusses issues regarding the definition of a clinical phenotype, trial design, efficacy and safety for new drug products under development. “In particular, the guidance addresses development programs for the treatment of vasomotor rhinitis (VMR), which is a subtype of NAR,” FDA says
Nonallergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry
Allergic Rhinitis: Developing Drug Products for Treatment: Guidance for Industry