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Supernus Resubmits New Drug Application for Parkinson's Treatment Device
Supernus Pharmaceuticals resubmitted its new-drug application for a device to treat patients with Parkinson's disease to the Food and Drug Administration.
The Rockville, Md. biopharmaceutical company said on Thursday it believes it has addressed the questions in an April letter from the FDA about the review of its SPN-830 apomorphine-infusion device to treat "off" episodes in Parkinson's patients. The company, which focuses on central-nervous-system diseases, said the agency indicated its review was complete, but two areas either required additional review or more information from the company. No clinical or safety issues were identified at that time.
Off periods can occur in people with Parkinson's disease when there is a spike in symptoms in between treatment doses. The SPN-830 device is specifically meant to continuously treat motor fluctuations associated with these episodes.
The Rockville, Md. biopharmaceutical company said on Thursday it believes it has addressed the questions in an April letter from the FDA about the review of its SPN-830 apomorphine-infusion device to treat "off" episodes in Parkinson's patients. The company, which focuses on central-nervous-system diseases, said the agency indicated its review was complete, but two areas either required additional review or more information from the company. No clinical or safety issues were identified at that time.
Off periods can occur in people with Parkinson's disease when there is a spike in symptoms in between treatment doses. The SPN-830 device is specifically meant to continuously treat motor fluctuations associated with these episodes.
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Arrayfunction : Do you have any experience with Phase 4 / aftermarket trials for medical devices or durable medical equipment? That's something I would like to educate myself on but I honestly have a much harder time with devices. For one, my company doesn't really do those anymore. But mainly it's the extra categories (e.g. FDA authorized de novo and approval on the basis of similarities to an established device) that I struggle with.
I'd appreciate the help! But no worries if not
Jaguar8 OP Arrayfunction : No. I do not come from any clinical research companies and/or pharma which does Ph 4.
Arrayfunction Jaguar8 OP : Thanks!