09:17 AM EDT, 04/08/2024 (MT Newswires) -- Supernus Pharmaceuticals ( SUPN ) said Monday the Federal Drug Administration had issued a Complete Response Letter in response to its new drug application for SPN-830, a setback for the investigational potential treatment for Parkinson's disease symptoms.

The response indicates that the FDA has declined to approve the application in its present form for SPN-830, an apomorphine infusion device for the continuous treatment of motor fluctuations in Parkinson's disease.

The FDA wants more product quality data and more information about the delivery device, Supine said.

The biopharmaceutical company said it will consider steps for resubmission and approach the manufacturer of the delivery device to obtain more details.

Supernus Pharmaceuticals ( SUPN ) shares were down 9% in recent premarket trading activity.

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