FDA Needs More Data Before Deciding on Apomorphine Infusion Device

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Supernus Pharmaceuticals regarding the New Drug Application (NDA) for SPN-830, an apomorphine infusion device for the continuous treatment of motor fluctuations (off episodes) in adults with Parkinson disease.

Apomorphine, a non-ergoline dopamine agonist, is believed to treat off episodes associated with Parkinson disease through stimulation of postsynaptic dopamine D2-type receptors within the caudate-putamen in the brain. SPN-830 provides a continuous subcutaneous infusion of apomorphine through an infusion pump.

Supernus had originally submitted the NDA for SPN-830 in September 2020. The application included data from the phase 3 TOLEDO study (ClinicalTrials.gov Identifier: NCT02006121) and a supportive open-label study (ClinicalTrials.gov Identifier: NCT02339064).

The FDA subsequently issued a Refusal to File (RTF) letter stating that the NDA was not sufficiently complete to permit a substantive review. In December 2021, the Company resubmitted the NDA after the Agency provided additional guidance related to the requested documents and reports cited in the RTF letter.

In the CRL, the Agency noted that additional information and analysis related to the “infusion device and drug product across several areas of the NDA including, but not limited to, labeling, product quality and manufacturing, device performance and risk analysis” would be required. The letter did not request additional efficacy or safety studies.

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