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Glaxo SmithKline announced today that it is terminating the development of brecanavir, a new protease inhibitor licensed from Vertex, because of problems in developing an oral formulation of the drug.

The drug had reached phase II trials and early results in treatment-naïve and treatment-experienced patients appeared promising. However, today the company said in a press release: “This decision has been taken as we have been unable to develop a viable oral dosage formulation capable of delivering the desired drug levels in patients with multi-drug-resistant HIV.”

People currently receiving brecanavir in clinical trials will be moved over to other therapies as appropriate.

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.

oral

Refers to the mouth, for example a medicine taken by mouth.

treatment-naive

A person who has never taken treatment for a condition.

treatment-experienced

A person who has previously taken treatment for a condition. Treatment-experienced people may have taken several different regimens before and may have a strain of HIV that is resistant to multiple drug classes.

toxicity

Side-effects.

The decision to discontinue development is a blow to Glaxo SmithKline’s hopes to develop a portfolio of new anti-HIV drugs. Last year the company was forced to abandon development of an agent in a new class of drugs, a chemokine antagonist, because of serious liver enzyme elevations and liver toxicity in three patients.