FDA Decision on Apomorphine Infusion Device Delayed Again

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

This is the second CRL the Company has received for SPN-830. The drug/device combination therapy provides a continuous subcutaneous infusion of apomorphine through an infusion pump. Efficacy was established based on data from the phase 3 TOLEDO study (ClinicalTrials.gov Identifier: NCT02006121) and a supportive open-label study (ClinicalTrials.gov Identifier: NCT02339064).

In the letter, the FDA cited that additional information on product quality and the infusion device was still needed before the Agency could make a decision on approval. No clinical or safety issues were noted in the CRL.

“We remain committed to bringing SPN-830 to the market as an important treatment option for PD patients who experience motor fluctuations associated with off episodes,” said Jack Khattar, President & CEO of Supernus. “We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA.” 

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.