New formulation of nelfinavir clears key hurdle on road to EU approval

Michael Carter
Published: 28 January 2004

A new formulation of the protease inhibitor nelfinavir (Viracept), that reduces the drug’s daily pill burden by 60% has received a positive opinion from the European Committee on Proprietary Medical Products (CPMP), a key stage on the road to European marketing approval.

Currently, it is necessary to take five 250mg nelfinavir pills twice daily. The drug has been reformulated into 625mg pills, reducing the number of pills that need to be taken in each dose to two. In a study presented to the International AIDS (IAS) Conference in Paris last summer, 91% of patients who switched from the 250mg pills to the 625mg formulation said that they preferred it.

As well as retaining its potency, the new 625mg formulation of nelfinavir appears to cause fewer gastrointestinal side-effects. Diarrhoea is a frequently reported side-effect of nelfinavir, and the study presented to the IAS conference found that patients taking the 625mg formulation had better bowel function. A different study presented to the same conference found that reduced pill burden improved patient adherence to HAART.

The 625mg nelfinavir formulation is expected to gain formal European marketing authorisation later in 2004.

An international study to assess the long-term effectiveness and safety of nelfinavir is currently underway. Nelfinavir is not currently recommended for first-line therapy in the treatment guidelines of the British HIV Association, which only endorses NNRTIs or boosted protease inhibitors in initial HIV treatment regimens.

Source

Roche press release

Reference

Nieto-Cisneros L et al. Roche Viracept 625mg film-coated tablets: investigation of safety and gastrointestinal tolerability of this new formulation in comparison with 250mg film-coated tablets in HIV patients. Antiretroviral Therapy 8 (Suppl.1), abstract 548, s331, 2003.

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