The NDA for SPN-830 is supported by data from an extensive development program that includes the phase 3 TOLEDO study and a supportive open-label study. The New Drug Application (NDA) for SPN-830 ...
Credit: Thinkstock. SPN-830 provides a continuous subcutaneous infusion of apomorphine through an infusion pump. The Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act ...
Supernus Pharmaceuticals' ONAPGO for Parkinson’s Disease received FDA approval, providing a basis for optimism despite past regulatory challenges with SPN-830. The company is methodically planning ...
Indian clinical trial data for drugs like safinamide and apomorphine pump therapy are key for global pharma to seek US FDA approval. This along with specific therapies like gene based treatments ...
After successfully launching the D-mine Pump, a micro infusion device designed to provide precise continuous subcutaneous drug delivery for PD patients, the product family has been extended to include ...
Levodopa is the gold standard for Parkinson's disease treatment, but not all patients find success with commonly prescribed tablets and pills. For those with limited motor control, a more sustainable ...
Parkinson's is a neurodegenerative disorder that affects millions of people worldwide. This condition is commonly associated with ageing, as it usually affects people 65 years of age and older. But ...
Hyderabad: Drug Controller General of India (DCGI) has given licence for new device-aided therapy for Parkinson’s disease. London-based researchers and Nizam’s Institue of Medical Sciences (NIMS) ...
Patients should receive training on the proper use of the delivery device prior to starting treatment. The Food and Drug Administration (FDA) has approved Onapgo™ (apomorphine hydrochloride [HCl]) for ...
SALZBURG, Austria--(BUSINESS WIRE)--Launched as the D-mine ® Pump, this portable micro infusion device recently received European CE approval and is currently being launched in several European ...
New drug Apomorphine to treat Parkinson’s disease is now available in a Bengaluru hospital. A private hospital in Bengaluru in a tie-up with Britannia Pharmaceuticals, a UK-based pharmaceutical ...