Tudorza pressair i.e. aclidinium bromide recently approved by the US FDA which is very good bronchodilator long term management of the brochospasm which generally occurs due to bronchospasm (narrowing of the airways in the lung) which normally associated with COPD (chronic obstructive pulmonary disease), including chronic bronchitis and emphysema.
In case of COPD, it makes it difficult to breathe.
There are two main forms of COPD:
- Chronic bronchitis, which involves a long-term cough with mucus
- Emphysema, which involves destruction of the lungs over time
Most of the patients with COPD have a combination of both the conditions.
COPD is caused by noxious particles or gas, most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lungs.
“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research.
“The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease.”
The safety and efficacy of Tudorza Pressair were demonstrated in three randomized, placebo-controlled confirmatory clinical trials that included 1,276 patients ages 40 and older with a clinical diagnosis of COPD. Those treated had a smoking history of at least one pack a day for 10 years.
- Tudorza Pressair may cause serious side effects, including paradoxical bronchospasm, new or worsened increased pressure in the eyes (acute narrow-angle glaucoma), or new or worsened urinary retention. Tudorza Pressair should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years.
- Side effects reported by patients using Tudorza Pressair include headache, inflammation of the nasal passage (nasopharyngitis), and cough.
Currently, Tudorza Pressair is distributed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.
Source: US FDA
Drugs are never been used after they met their expiry dates. But according to scientists some drugs product which may be over-the-counter drugs or from other category may be used even after the their expiration. In this context U.S. Military performed a million dollar research on the efficacy of the drug products with expiry date all about 27 years ago on more than 100 products available in the market at that time. And a the research succeeded scientists were surprised with the results which proves that 90% of the drugs can be used even after the expiry date with the same efficacy.
