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Indacaterol Novartis/skyePharma.

Graeme P Currie¹

¹Aberdeen Royal Infirmary, Foresterhill Road, Aberdeen, AB25 2ZN, UK. graeme.currie@nhs.net

Current Opinion in Investigational Drugs (London, England : 2000)

|May 30, 2006

Summary

Novartis is developing a new dry powder inhaler for indacaterol, a bronchodilator, to treat asthma and COPD. Phase III trials were anticipated to begin in early 2006, with regulatory submission planned for 2007.

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Area of Science:

Respiratory medicine
Pharmaceutical development

Background:

Indacaterol is a long-acting beta2 agonist and bronchodilator.
Asthma and chronic obstructive pulmonary disease (COPD) are significant respiratory conditions.

Purpose of the Study:

To develop a multidose dry powder inhaler (MDPI) formulation of indacaterol.
To evaluate the potential of this new formulation for treating asthma and COPD.

Main Methods:

Collaboration between Novartis and SkyePharma for formulation development.
Planning and initiation of Phase III clinical trials.

Main Results:

A multidose dry powder inhaler formulation of indacaterol is under development.
Phase III clinical trials were expected to commence in early 2006.

Conclusions:

The indacaterol MDPI formulation shows potential for treating asthma and COPD.
Regulatory submission was planned for 2007, indicating progress in development.

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