Following problems in the manufacturing process,
Abbott Laboratories last year suspended the production of the original capsule
formulation of their protease inhibitor ritonavir (Norvir™). Whilst the
company worked on a new formulation, users of the drug were switched to a liquid
form; a bitter-tasting syrup which some users find unpalatable.
The new formulation (Norvir™ Soft Elastic
Capsule) has been studied by drug licensing authorities over the past few
months. European approval is expected imminently, and Abbott Laboratories are
now able to make the new capsules available through a named patient programme.
Such schemes allow investigational therapies to be provided to a ‘named patient’
whose doctor applies on his/her behalf.
Norvir™ Soft Elastic Capsules have been designed
to be bioequivalent to the old product. They contain 100mg ritonavir, and are
slightly fatter and a little shorter than their predecessor. Once dispensed,
they can be stored out of the fridge for up to a month (so long as room
temperature is below 25 degrees).
Doctors who would like further information on the
named patient programme should call the scheme’s Administrator on 01628 644370.
(Note that licensing regulations prevent the NPP Administrator from discussing
the programme with non-healthcare professionals – people with HIV should speak
to their doctor instead.)