French Health Authority approves enteric coated ddI

Bristol-Myers Squibb have received approval from the French Health Authority for a new formulation of its anti-HIV drug didanosine (ddI, VidexTM). In a statement released in London it said the French approval was the first in the world for the new formulation of ddI capsules, to be known in France as ‘gelules gastro-resistantes.’ The approval forms the basis of a mutual recognition application in the other 14 member states of the European Union.

The new capsules contain coated granules designed to protect didanosine, the active ingredient, from degrading until it has passed through the stomach, thus eliminating the need for a buffer. The antacid buffer in the previously available formulation had a tendency to cause gastrointestinal upset.

Agouron Pharmaceuticals, Inc. have announced that the Food and Drug Administration (FDA) has approved a film-coated tablet version of Nelfinavir Mesylate (ViraceptTM). This new formulation follows criticism that the current version was dry, chalky, difficult to swallow and had a tendency to break easily during storage. The dosage strength will remain the same.

Comment

Whilst film coated nelfinavir is now on pharmacy shelves in the US, the dossier for European approval has not even been submitted to regulatory authorities. This delay means it is unlikely that Europeans will benefit from the improved tolerability of this formulation before sometime next year. The reason for these delays is unknown. Roche Pharmaceuticals are responsible for nelfinavir in Europe.

A ‘hardened’ version of nelfinavir will be distributed in Europe from May this year as an intermediate step to improve the usability of this drug.