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Weekly Drug News Round-Up: February 1, 2017

Teva's AirDuo RespiClick FDA-Approved for Asthma

AirDuo RespiClick contains the same active ingredients as Advair Read More...

Teva announces FDA approval of AirDuo RespiClick (fluticasone propionate and salmeterol), a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination for adolescent and adult patients with asthma. AirDuo RespiClick comes as a breath-activated, multi-dose dry powder inhaler formulation. In Phase 3 trials, AirDuo RespiClick showed clinically relevant and greater benefit compared with placebo in the improvement of lung function after 12 weeks of treatment as measured by Forced Expiratory Volume in one second (FEV1). The most common adverse reactions (incidence ≥3%) were nasopharyngitis (common cold), headache, cough, oral candidiasis (thrush) and back pain.

Teva's ArmonAir RespiClick Approved for Asthma 

ArmonAir RespiClick contains the same active ingredient as Flovent Read More...

The FDA also approved another Teva asthma treatment this week: ArmonAir RespiClick (fluticasone propionate) is an inhaled corticosteroid in a breath-activated, dry powder inhaler for the treatment of asthma. It is used in adolescent and adult patients. The approved strengths of ArmonAir RespiClick, expected to be available later this year, are: 55 mcg, 113 mcg, and 232 mcg administered as one inhalation twice daily. Common side were nasopharyngitis (common cold), headache, cough, oral candidiasis (thrush) and upper respiratory tract infection.

Latuda Cleared to Treat Adolescents with Schizophrenia

In studies in adolescents, Latuda was well tolerated with limited effects on weight and metabolic parameters Read More...

Schizophrenia is a chronic, serious brain disorder. Symptoms such as hallucinations and delusions usually start between ages 16 and 30. Sunovion’s Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression in adults, and has received FDA approval to treat younger patients, adolescents aged 13 to 17 years. The efficacy of Latuda in adolescents with schizophrenia was established in one 6-week study where patients received fixed doses of Latuda 40 mg/day, Latuda 80 mg/day or placebo. At study endpoint, Latuda 40 mg/day and 80 mg/day were associated with statistical and clinical improvement in symptoms of schizophrenia compared to placebo.

Symbicort Approved for Asthma in Patients 6 to 12 Years of Age

Symbicort was first approved by the FDA in the US in July 2006 Read More...

AstraZeneca’s Symbicort (budesonide and formoterol) is a combination of a corticosteroid and a long-acting bronchodilator used for treatment of asthma and chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. This week, the FDA granted AstraZeneca six months of pediatric exclusivity for Symbicort based on the evaluation of studies conducted in children with asthma age 6 to 12 years. Symbicort is currently approved in the US to treat asthma in patients 12 years and older and for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults.

Lower Dose of Linzess Approved for Chronic Idiopathic Constipation

Linzess is thought to work by increasing intestinal fluid secretion, transit time and modulating pain Read More...

Ironwood Pharmaceuticals and Allergan announced that the FDA has approved a 72 mcg dose of Linzess (linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients. Linzess is a guanylate cyclase-C agonist also indicated for use in adults with irritable bowel syndrome with constipation (IBS-C). Linzess is now FDA-approved in three strengths: 290 mcg for adults with IBS-C, and 145 mcg and the new 72 mcg for the treatment of adults with CIC. Clinical trials with the 72 mcg dose met the primary endpoint of statistically significant improvement in Complete Spontaneous Bowel Movements compared to placebo over 12 weeks. Diarrhea was the most common, but dose-related side effect.