Sunovion Pharmaceuticals Inc.: Kynmobi

As communicated to you in a November 21, 2018, Discipline Review (DR) letter, the human factors (HF) validation study conducted for Kynmobi does not provide sufficient evidence to demonstrate that the proposed product can be used safely and effectively by intended users for its intended uses and use environments.

Additionally, you have not provided data to demonstrate that your proposed mitigations are effective and do not introduce new use-related risks.

We acknowledge your December 7, 2018, formal response to the DR letter, and note that your response provided additional information and your plan to address the Agency's concerns about your human factors (HF) validation study results and the © packaging.

We acknowledge that you have implemented our IFU, container label, and carton labeling recommendations.

We also note that Kynmobi is intended for the acute, intermittent treatment of "OFF" episodes associated with Parkinson's disease; therefore, delay in therapy (e.g., due to difficulty opening the © packaging) would cause the user to remain in the OFF state.

A human factors validation study using the intend-to-market user interface (i.e., oe packaging) is needed to demonstrate that the mitigations are effective and do not introduce new risks.

Complete Study CTH-203 and provide the final report for Study CTH-203, which is necessary to justify the relevance of comparative data with your proposed product (Kynmobi) and Apo-go to support the scientific appropriateness of reliance on FDA's finding of safety for Apokyn.

In addition, clearly describe the data and information that supports the scientific bridge between your proposed product (Kynmobi) and the listed drug relied upon (Apokyn), which may include data and information supporting a bridge between Kynmobi and Apo-go and between Apokyn and Apo-go.

Present this information for each study phase (e.g., titration and maintenance) and for all patients in the overall safety population.

Present analyses of the association between oropharyngeal adverse events and systemic hypersensitivity, including the temporal relationship between oropharyngeal and systemic hypersensitivity events, if any.

8. Provide English translations of current approved foreign labeling not previously submitted.

The datasets should include all patients in the safety population from initiation of clinical studies through an appropriate cut-off date for your re-submission.

The Summary of Clinical Safety should be updated with attention to all adverse events of special interest, especially those suggesting hypersensitivity reactions.

Perform an analysis by dose and duration of exposure until the time of AE development in cases identified by MedDRA SMQ for hypersensitivity and angioedema.