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 subutaneous infusion of apomorphine through an infusion pump The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to ...
If a patient with Parkinson’s disease fits into the “5-2-1” screening criteria– five times of oral tablet, stiffness for two hours and one hour of uncontrollable movements despite medication– laid ...