The Demand for Roflumilast Set to Rise for COPD Patients


RoflumilastRoflumilast, CAS number 162401-32-3, is also known by the brand name Daliresp. The patent for Daliresp, which is marketed by Forest Pharmaceuticals, is due to expire on Jan 27, 2015. Patients with severe chronic obstructive pulmonary disease, or COPD, find that treatment with roflumilast is efficacious at reducing flare ups of their condition, especially those patients who suffer from chronic bronchitis. As an inhibitor of the enzyme called phosphodiesterase type 4, or PDE-4, roflumilast is the first and only FDA approved selective PDE-4 inhibitor. The use of roflumilast as a bronchodilator is not recommended, as it is only indicated to decrease exacerbations and the worsening of COPD symptoms.

The leading cause of COPD is cigarette smoking, and unfortunately the symptoms only get progressively worse over time. Patients suffering from COPD experience symptoms such as breathlessness, chronic cough, and excessive phlegm. The treatment option of roflumilast is a boon for the COPD patient population, as a reduction in the frequency of flare-ups and exacerbations are essential for helping these patients cope with this debilitating disease. Offered as a 500 microgram tablet, roflumilast is typically prescribed once daily, and may be taken with or without food. Side effects may include nausea, headache, back pain, dizziness, diarrhea, insomnia and a decreased appetite. Roflumilast should not be used to treat sudden breathing problems and is not recommended for anyone under age 18.

Clinical studies of roflumilast touted the safety and efficacy of this novel drug. Two phase III clinical trials involved more than 1,500 patients, all of whom were 40 years of age and older. Participants in these trials had a history of COPD associated with chronic bronchitis, and had experienced an exacerbation 12 months prior to the study. The studies showed a remarkable reduction in moderate to severe exacerbations by 17 percent per patient per year. In addition, when researchers added a standard bronchodilator to the roflumilast therapies another significant reduction of exacerbations was observed.

The National Heart, Lung, and Blood Institute estimates that 12 million adults have COPD, and another 12 million are undiagnosed or developing COPD. Surprisingly, chronic obstructive pulmonary disease is predicted to be the third leading cause of death in the U.S. by 2020. There is an urgency for researchers to develop generic formulations of roflumilast, and LGM Pharma is a provider of this API product. Clients of LGM Pharma are certain to receive complete assistance throughout the research and development process.

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