New drug Tudorza Pressair is given FDA backing for the treatment of COPD

This week has seen yet another new drug been given a clearance by The Food and Drug Administration (FDA), following the recent seal of approval for two new weight loss medications, Qsymia and Belviq, as we reported last week.

On this occasion, the drug to be given an authorisation for public use is a twice-daily inhaled medication named ‘Tudorza Pressair’, which is used to help treat symptoms of bronchospasm. This is associated with chronic obstructive pulmonary disease (COPD), aka ‘smoker’s cough’.

COPD is a term used for numerous conditions, including chronic bronchitis and emphysema, and is similar in certain characteristics to asthma. Bronchitis and emphysema are commonly co-existing diseases of the lungs in which the airways become narrowed, thus making it difficult for air to get in or out of the lungs.  Obvious symptoms can include chronic cough, tightness in the chest, and excessive phlegm.

Asthma and COPD can exist in the same person. However, in contrast to asthma, the inflammation of the lungs with COPD is not triggered by allergies and does not respond well to anti-inflammatory medication. In 2005, there were over 3 million deaths worldwide linked to COPD, with the main cause being the damaging effects of cigarette smoking.

On Tuesday, Spain’s biggest pharmaceutical company Almirall, and US drugmaker Forest Laboratories, confirmed they had been given the coveted FDA green light for Tudorza Pressair. This followed a slight hiccup back in March when the FDA demanded that it wanted a three-month extended time period to analyse the review data supporting the New Drug Application for aclidinium bromide (the powder ingredient within Tudorza Pressair).

Despite entering into an already competitive market where highly popular effective medications such as Ventolin can alleviate COPD symptoms, analysts at Sanford Bernstein say that sales of the Forest/Almirall drug could hit $164 million by 2015.

A spokesperson at Forest commented saying, “As the first long-acting inhaled anticholinergic agent approved in over 8 years for COPD, Tudorza will be an important treatment option.”
Curtis Rosebraugh, MD, Office of Drug Evaluation II, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland, said, “COPD is a serious disease that gets worse over time. The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease.”

However, the FDA have also warned that the drug may cause some serious side effects such as paradoxical bronchospasm, new or worsened urinary retention, or new or worsened pressure in the eyes (known as acute narrow-angle glaucoma). The FDA also says the medication is not fit to be used as a rescue therapy to help aid sudden breathing difficulties such as acute bronchospasm.

When Medical Specialists Pharmacy know more about this and other medications that are being approved by the FDA to help with asthma or COPD, we will update our patients immediately. In the meantime, Medical Specialists Pharmacy provides a huge range of medications to help asthma sufferers, all at great prices. If you have already been prescribed an inhaler, have lost your inhaler, or run out and cannot get a prescription immediately, we are able to supply you an inhaler to help your asthma symptoms.   After undergoing a private and confidential online consultation with one of our Doctors, if you are suitable they will then write you a prescription which is passed to our in-house Pharmacists and dispensed to a location of your choice. This is all done discretely and within just 24 hours. We offer both blue (relievers) inhalers such as Ventolin and Salbutamol, and brown (preventers) inhalers such as Qvar Beclomethasone, Qvar Easi-Breathe, and Pulvinal Beclomethasone.