Intrathecal analgesic to be launched next week
A new intrathecal analgesic called ziconotide
(Prialt) will be launched by Eisai next week.
Ziconotide has been authorised by the
European Medicines Agency (EMEA) under “exceptional circumstances”.This means that,
due to the rarity of the indication for which
the product is intended, it has not been possible
to obtain complete information on the
product and the EMEA will review any new
information each year and update the summary
of product characteristics as necessary.
The new analgesic is licensed for intrathecal
use for the treatment of severe, chronic
pain. It is a synthetic analogue of a ω-conopeptide,
MVIIA, found in the venom of the
Conus magus marine snail.An N-type calcium
channel blocker, it regulates neurotransmitter
release in specific neuronal populations responsible
for the spinal processing of pain.
Ziconotide should be administered as a
continuous infusion. An internally implanted
mechanical infusion pump is recommended
for prolonged periods of administration, owing
to the risk of meningitis secondary to prolonged
catheterisation of the intrathecal space.
Cognitive and neuropsychiatric adverse
effects, typically reversible within one to four
weeks after discontinuation, are common and
the dose should be reduced or drug discontinued
if signs or symptoms appear. |