Isotopes are variants of a particular chemical element such that, while all
isotopes of a given element have the same number of protons in each atom, they
differ in neutron number.
• The short relaxation time of deuterium of the spin 1 (quadrupole) provides substantial sensitivity
for nuclear magnetic resonance spectroscopy (MRS).
• When D2O is administered in a bolus
fashion to a specific tissue or organ in vivo, the deuterium MRS intensity time
course can be analyzed to measure the rate of blood flow and tissue perfusion.
•FDA
responds to Teva’s NDA with complete response letter for
Huntington’s chorea drug
•SD-809
is the first deuterated product that the FDA has reviewed.
•FDA
just asked Teva to analyze blood levels of certain
metabolites, which are not novel and are similar in subjects who take either tetrabenazine or deutetrabenazine.
•The
FDA has requested no further clinical trials.
•Teva will continue to work closely with the
FDA to bring SD-809 to the market as quickly as possible,” said Michael Hayden,
M.D., Ph.D., Teva’s president of global research and
development and CSO