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Prosonix Initiates Phase 2 Clinical Study with PSX1002 in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Date:5/21/2013

clinical study of a drug formulation that we have wholly created and developed in-house using our unique particle engineering technology and Respiratory Medicine by Design approach. This important milestone, along with the planned EU filing of our lead product PSX1001 in the first half of 2014, highlights the rapid progress that Prosonix is making, and the significant value we are generating for all our stakeholders who have backed our respiratory focused strategy in mono and combination products."

About COPD

COPD is a long term, progressively destructive and life-threatening disease of the lungs, generally caused by cigarette smoking. The most common symptoms of COPD are breathlessness, production of abnormal sputum (a mix of saliva and mucus in the airway), and a chronic cough. Performance of everyday activities may be severely curtailed and overall quality of life significantly impaired. COPD is not curable, but treatment ameliorates symptoms and may slow the progress of the disease.

According to the World Health Organization, approximately 65 million people worldwide had COPD in 2004 and it is predicted to become the third leading cause of death by 2020. A limited number of mono and combination therapies are approved for this indication and together these products generated sales of more than $8 billion in 2011 in the seven major markets. LAMAs accounted for approximately $3 billion in sales from this total and Datamonitor (November 2011, HC000218) estimates that sales of this class of product will remain stable through 2020.

Further details about the study

The randomised, double-blind, single-dose study will investigate the effects on expiratory lung function, tolerability and safety of a range of doses of orally inhaled PSX1002 vs placebo delivered via pressurised metered dose inhaler (pMDI) in up to 40 male and female patients diagnosed with moderate or severe COPD.

The primary endpoint of the study is imp
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