FDA Approves Duaklir Pressair

In continuation of my update on formoterol 

Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease,  announced the US Food and Drug Administration (FDA) has approved Duaklir for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Duaklir is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide (400 mcg) and long-acting beta-agonist (LABA) formoterol fumarate (12 mcg) administered twice-daily via the breath-actuated inhaler Pressair®.  Circassia is on track to launch Duaklir in the United States in the second half of 2019 via its dedicated COPD sales force.

The Duaklir approval is based on a broad clinical database, including data from three phase III studies, ACLIFORM, AUGMENT and AMPLIFY. The label also includes clinical data from the phase IV ASCENT study, which shows aclidinium therapy is effective at reducing COPD exacerbations.  As a result, Duaklir® is the only twice-daily LAMA / LABA in the United States with COPD exacerbation data included in its prescribing information.

Steve Harris, Circassia’s Chief Executive, said: “We are delighted with the FDA approval of Duaklir, which we believe will provide a valuable treatment option for the significant number of patients with COPD in the United States. The addition of Duaklir to our portfolio further strengthens our range of marketed respiratory products and we look forward to launching it in the US in the coming months alongside our aclidinium monotherapy, Tudorza, as part of the significant LAMA / LABA market that is predicted to grow rapidly over the coming years.”

Michael Asmus, Circassia’s Vice President, US Medical Affairs, said: “With guidelines recommending combined LAMA and LABA therapy for a number of COPD patient groups, we believe Duaklir will make an important contribution to the treatment of this debilitating disease. Dukalir’s approval is based on a broad clinical database, including data demonstrating a reduction in the risk of COPD exacerbations driven by its aclidinium component, and we look forward to making this new therapeutic option available to patients across the United States.”

 Aclidinium bromide

  Formoterol

https://en.wikipedia.org/wiki/Aclidinium_bromide

https://www.drugbank.ca/drugs/DB00983

Combination drug therapy safe, effective in treating asthma patients

In continuation of my update formoterol and  budesonide

A post-marketing safety study mandated by the U.S. Food and Drug Administration has shown that a combination drug therapy for the treatment of asthma is safe and effective.

The therapy tested consisted of a long-acting beta agonist, formoterol, added to an inhaled glucocorticoid, budesonide.

 Formoterol     Budesonide 

"Our study showed no significant increase in serious adverse events in the combination therapy," said Stephen Peters, M.D., Ph.D., professor of pulmonary, critical care, allergy and immunologic diseases at Wake Forest Baptist Medical Center and lead author of the study.

"A large number of studies have shown that this type of combination therapy really helps asthma control and decreases symptoms. Our findings, in combination with results from another FDA-mandated safety study, are very reassuring to those of us who treat asthmatic patients."

The study is published in the Sept. 1 issue of the New England Journal of Medicine.

In this multicenter, double-blind, 26-week study, the scientists evaluated whether the addition of formoterol to budesonide maintenance therapy increased the risk of serious asthma-related events in patients with moderate to severe asthma. Study participants were age 12 or older, had persistent asthma, received daily asthma medication and had one to four exacerbations in the previous year.

Of the 11,693 patients enrolled in the study, an asthma-related event occurred in 43 patients who received the combination therapy of budesonide and formoterol and in 40 patients who received only budesonide. Two asthma-related deaths were reported in the combination arm of the study and none in the single-therapy group, which is not statistically significant.

In addition, a secondary finding showed a 16.5 percent decrease in asthma exacerbations in the combination therapy group as compared to the group receiving budesonide.

Overall, the researchers found that treatment with budesonide-formoterol was associated with a lower risk of asthma exacerbations than budesonide and a similar risk of serious asthma-related events.

Bevespi Aerosphere Approved by the FDA for Patients with COPD

In continuation of my update on formoterol

AstraZeneca today announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

glycopyrrolate formoterol 

Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “With the approval of Bevespi Aerosphere we are pleased to provide patients with the first LAMA/LABA in a pressurised metered-dose inhaler, delivered using our unique formulation technology. LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, which enables patients to breathe better and may help them be more active.”

Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). The FDA approval is based on the PINNACLE trial programme, which demonstrated that Bevespi Aerosphere achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its mono-components and placebo.

Bevespi Aerosphere is the first product approved using AstraZeneca’s Co-Suspension Technology. This technology enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010).

About COPD

COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD. It is estimated that eight out of 10 patients suffer symptoms at night, such as an irritative cough and difficulty breathing, frequent nocturnal awakenings, which leads to insomnia, worry and anxiety.

Bevespi Aerosphere Approved by the FDA for Patients with COPD

In continuation of my update on Formoterol

 Formoterol     glycopyrrolate

AstraZeneca announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “With the approval of Bevespi Aerosphere we are pleased to provide patients with the first LAMA/LABA in a pressurised metered-dose inhaler, delivered using our unique formulation technology. LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, which enables patients to breathe better and may help them be more active.”

Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). The FDA approval is based on the PINNACLE trial programme, which demonstrated that Bevespi Aerosphere achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its mono-components and placebo.

Bevespi Aerosphere is the first product approved using AstraZeneca’s Co-Suspension Technology. This technology enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010).

Bevespi Aerosphere Approved by the FDA for Patients with COPD

Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

In continuation of my update on Budesonide

We know that, Budesonide is a glucocorticoid steroid for the treatment of asthma and non-infectious rhinitis (including hay fever and other allergies), and for treatment and prevention of nasal polyposis. In addition, it is used for Crohn's disease (inflammatory bowel disease).

It is marketed by AstraZeneca as a nasal inhalant under the brand name Rhinocort (in Denmark, as Rhinosol), as an oral inhalant under the brand name Pulmicort (in Israel, Budicort), and as either an enema or a modified-release oral capsule under the brand name Entocort. It is also sold in combination with formoterol (Oxis) in a single inhaler, under the brand name Symbicort. In Brazil it is marketed by Eurofarma under the brand name Noex. Entocort EC is an oral capsule marketed in the United States by Prometheus Laboratories.

Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

Formoterol drug improves fat burning and protein metabolism in men

We know that, Formoterol  or eformoterol  is a long-acting β₂-agonist used in the management of asthma and/or chronic obstructive pulmonary disease (COPD). It is marketed in four forms: a dry-powder inhaler (DPI), a metered-dose inhaler (MDI), an oral tablet, and an inhalation solution, under various trade names including Foradil/Foradile (Schering-Plough in the U.S., Novartis rest of world), Oxeze (AstraZeneca), Atock (Astellas), Atimos Modulite (Trinity-Chiesi), and Perforomist (Dey).

Now researchers lead by Dr. Paul Lee of  Garvan Institute of Medical Research in Sydney, have for the first time reports that research in animals has shown that formoterol can stimulate the growth of muscle and the burning of fat...

Formoterol drug improves fat burning and protein metabolism in men