Norvir™ Soft Elastic Capsule named patient programme

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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

Glossary

formulation

The physical form in which a drug is manufactured or administered. Examples of formulations include tablets, capsules, powders, and oral and injectable solutions. A drug may be available in multiple formulations.

named patient basis prescribing

A means of access to an unlicensed drug, in which a doctor requests supplies from its manufacturer for a specific individual.

investigational

In medicine, a drug that is approved by the regulatory authorities (Food and Drug Administration, European Medicines Agency) for testing in clinical trials, but not yet approved for commercial marketing and sale. Also called experimental drug, investigational agent, and investigational new drug (IND).

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.)

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