Acorda Therapeutics has announced that clinical trials of Plumiaz diazepam nasal spray have failed to demonstrate bioequivalence to Diastat rectal gel, which means that the company is unable to re-file its 505(b)(2) NDA for the product. The FDA had issued a complete response letter (CRL) for the NDA in 2014. As a result, the company says that it is discontinuing … [Read more...] about Acorda discontinues development of Plumiaz diazepam nasal spray for seizures
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Study shows nicotine inhaler helps smokers quit
A study published in the journal Nicotine and Tobacco Research found that 32% of smokers using a nicotine MDI plus a nicotine patch quit for 6 months compared to 18% of smokers using a placebo MDI and a nicotine patch. The study enrolled 502 adults who smoked at least 9 cigarettes per day. According to the authors, "The present trial demonstrates that a simple … [Read more...] about Study shows nicotine inhaler helps smokers quit
NeOnc Technologies initiates Phase 1/2a clinical trial of intranasal perillyl alcohol for glioblastoma
US biotechnology company NeOnc Technologies has announced the initiation of a Phase 1/2a clinical trial of NEO100 intranasal perillyl alcohol (POH) for the treatment of glioblastoma multiforme (GBM), an aggressive brain cancer. Five-year survival for patients with GBM is only 3-5%. The trial is expected to enroll approximately 40 patients in total, and the first … [Read more...] about NeOnc Technologies initiates Phase 1/2a clinical trial of intranasal perillyl alcohol for glioblastoma
Survey shows pulmonologists prefer hand-held nebulizers to MDIs or DPIs for patients with severe COPD
An online survey of 205 pulmonologists and pulmonology fellows conducted by the American Thoracic Society and Sunovion Pharmaceuticals has found that two thirds of the physicians believe that hand-held nebulizers are superior to both MDIs and DPIs for the treatment of severe COPD, and 70% believe that hand-held nebulizers are superior to either MDIs or DPIs for the … [Read more...] about Survey shows pulmonologists prefer hand-held nebulizers to MDIs or DPIs for patients with severe COPD
EMA review finds that all ICS products carry similar risk of pneumonia but that benefits outweigh the risks
An EMA Pharmacovigilance Risk Assessment Committee (PRAC) review of published data from controlled clinical trials, observational studies, and meta-analyses has concluded that all inhaled corticosteroid (ICS) products appear to carry a similar risk of pneumonia when used to treat COPD patients but that the benefits of ICS treatment for COPD outweigh the risks. … [Read more...] about EMA review finds that all ICS products carry similar risk of pneumonia but that benefits outweigh the risks
Phase 3 trials of Sunovion’s nebulized glycopyrrolate meet primary endpoints
Sunovion has announced that the GOLDEN-3 and GOLDEN-4 Phase 3 clinical trials of SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD both met their primary endpoints. SUN-101, delivered via the PARI eFlow handheld nebulizer, demonstrated statistically significant improvement in FEV1 versus placebo after 12 weeks for both the 50 … [Read more...] about Phase 3 trials of Sunovion’s nebulized glycopyrrolate meet primary endpoints
Mast Therapeutics announces Phase 2 study of AIR001by the Heart Failure Clinical Research Network
Mast Therapeutics has announced that the Duke Clinical Research Institute will serve as the coordinating center for the Heart Failure Clinical Research Network (HFN) as it conducts a Phase 2 study of AIR001 sodium nitrite inhalation solution. Earlier this year, Mast reported positive results from a Phase 2a AIR001 for the treatment of heart failure that was conducted … [Read more...] about Mast Therapeutics announces Phase 2 study of AIR001by the Heart Failure Clinical Research Network
Eosinophil levels predict effect of ICS added to Spiriva + LABA on exacerbations
An analysis of data from Boehringer Ingelheim's WISDOM study showed that withdrawal of ICS for COPD patients using the Spiriva Handihaler tiotropium bromide DPI plus salmeterol is associated with a higher exacerbation rate in patients with ≥ 4% eosinophils in their blood, according to a new article published in Lancet Respiratory Medicine. Approximately 20% of the … [Read more...] about Eosinophil levels predict effect of ICS added to Spiriva + LABA on exacerbations
Respiratory specialists call out overdiagnosis of childhood asthma and overprescription of inhalers
In a leading article published in the Archives of Disease in Childhood, Andrew Bush and Louise Fleming of Royal Brompton Hospital and the National Heart and Lung Institute, Imperial College London assert that "the diagnosis of asthma has been trivialized and inhalers dispensed for no good reason, and have become almost a fashion accessory," which has contributed to … [Read more...] about Respiratory specialists call out overdiagnosis of childhood asthma and overprescription of inhalers
Study shows effectiveness of teach-to-goal inhaler education
A study published online ahead of print in the Annals of the American Thoracic Society (AnnalsATS) finds that a "teach-to-goal" inhaler education strategy reduced rescue inhaler misuse to 11% compared to 60% for a "brief instruction" approach immediately after education. Clinical outcomes were significant better for the teach-to-goal group, especially among patients … [Read more...] about Study shows effectiveness of teach-to-goal inhaler education