The U.S. Food and Drug Administration (FDA) has accepted Supernus Pharmaceuticals‘ new application seeking approval of its apomorphine infusion pump — known as SPN-830 — to treat motor fluctuations in people with Parkinson’s disease. A decision on the company’s request, resubmitted last month in the form…
Most people with Parkinson’s disease treated with SPN-830, an apomorphine infusion pump, report improvement in their health status. SPN-830 also reduced “off” time, when symptoms are not being adequately controlled, by an average of about three hours a day. That’s according to new results from an open-label…
The U.S. Food and Drug Administration (FDA) wants more information before it will approve Supernus Pharmaceuticals’ new drug application (NDA) resubmission of SPN-830, its apomorphine infusion pump. Supernus is seeking the approval of SPN-830 for the continuous treatment of “off” episodes in adults with Parkinson’s disease. These…
Supernus Pharmaceuticals has again applied to the U.S. Food and Drug Administration (FDA) requesting that its apomorphine infusion device (SPN-830), allowing continuous treatment of Parkinson’s disease motor symptoms, be approved. “SPN-830 is an important product candidate which, if approved by the FDA, represents a novel approach for PD…
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