This web site is part of the Business Intelligence Division of Informa PLC
This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
Drug Names(s): LAMA-LABA combination product, glycopyrrolate and formoterol fumarate HFA-MDI, GFF MDI, PT003, PT003 GFF, PT-003
PT003 is a long-acting muscarinic antagonist (LAMA) plus long acting ß2-agonist (LABA) combination product composed of glycopyrrolate and formoterol given twice daily from an hydrofluoroalkane metered dose inhaler (HFA-MDI). The HFA refers to the hydrofluoroalkane propellant, which is replacing chlorofluorocarbon (CFC) propellants due to environmental concerns. PT003 uses AstraZeneca’s Co-Suspension Technology.
Formoterol is a bronchodilator which has an extended duration of action (up to 12 hours) compared to short-acting ß2-agonists, which are effective for 4-6 hours. Inhaled muscarinic antagonists block the effect of acetylcholine at its muscarinic receptor, leading to airway smooth muscle relaxation and bronchodilation.
The Co-Suspension Technology uses porous, low-density phospholipid particles, which are designed to form a uniform suspension inside a pressurised metered-dose inhaler (pMDI) and distribution of drug crystals throughout the lungs for release at their sites of deposition. This technology provides a stable, homogeneous suspension designed to prevent sedimentation of drug crystals over time and to prevent drug crystals from interacting with one another, thus allowing for consistent dosing of one or more different drugs from a single pMDI.
Pearl and AstraZeneca
In June 2013, Pearl Therapeutics entered into a definitive merger agreement under which the Company will be acquired by AstraZeneca. The acquisition was completed in June 2013.
Bevespi Aerosphere News
Pink Sheet European CHMP Opinions and MAA Updates
Additional information available to subscribers only: