Discovery Laboratories has announced that data from a Phase 2a clinical trial of Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants show that the novel delivery technology performed acceptably and that Aerosurf was safe and well tolerated. During the study, the effects of three escalating doses of the … [Read more...] about Discovery Labs announces results from Phase 2a trial of Aerosurf
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JAMA Internal Medicine articles on the impact of the CFC to HFA transition criticize FDA and pharmaceutical companies
In a note accompanying a set of articles on the impact of the FDA's ban on the use of CFC propellants in metered dose inhalers and the transition to HFA inhalers, published online on May 11, 2015, the editors of JAMA Internal Medicine suggest that while any potential ecological benefits of the ban remain unclear, the benefits to the pharmaceutical industry are … [Read more...] about JAMA Internal Medicine articles on the impact of the CFC to HFA transition criticize FDA and pharmaceutical companies
Positive results for Adamis Pharmaceutical’s generic albuterol MDI
Adamis Pharmaceuticals has announced that a clinical study comparing its APC-2000 albuterol MDI with GSK's Ventolin Evohaler MDI met its primary endpoint, showing equivalence in change from baseline of FEV1 for both doses tested (100 and 200 mcg). The company said that the study, which involved 124 patients with mild to moderate asthma, took place "outside of the … [Read more...] about Positive results for Adamis Pharmaceutical’s generic albuterol MDI
Verona says interim results from Phase 1/2 study of RPL554 look promising
Verona Pharma has announced what it calls "encouraging interim results" from a Phase 1/2 study of a new formulation of its RPL554 PDE3/4 inhibitor for the treatment of COPD exacerbations. The company had announced the initiation of the 120-subject study of the nebulized formulation in January 2015 and now says that the trial is ahead of schedule. According to … [Read more...] about Verona says interim results from Phase 1/2 study of RPL554 look promising
Louiville, KY launches citywide inhaler sensor distribution program
A public/private partnership in Louisville, Kentucky called AIR Louisville will distribute 2,000 Propeller Health inhaler sensors to asthma patients across the city as part of a 2-year data collection program, according to Propeller. The FDA approved an updated version of the asthma tracking system, which includes sensors that snap onto standard MDIs, in April 2014. … [Read more...] about Louiville, KY launches citywide inhaler sensor distribution program
Positive Phase 3 results for PT003 glycopyrronium/formoterol MDI
AstraZeneca has announced that data from two Phase 3 studies of its PT003 glycopyrronium/formoterol MDI for the treatment of COPD showed statistically significant improvements in lung function for patients using PT003 compared to each of its components and to placebo. In 2013, Pearl Therapeutics announced the initiation of the Phase 3 program less than a month before … [Read more...] about Positive Phase 3 results for PT003 glycopyrronium/formoterol MDI
Apple introduces new app for asthma research
Apple has announced that its new ResearchKit open source software framework intended to help medical researchers collect patient data will be available next month, and the company has introduced a suite of apps used to collect the data. An Asthma Health app developed by the Icahn School of Medicine and LifeMap Solutions is now available on the App Store for download … [Read more...] about Apple introduces new app for asthma research
Study shows oxytocin nasal spray lowers calorie intake in men
Data to be presented at the upcoming annual meeting of The Endocrine Society show that healthy men treated with intranasal oxytocin consumed fewer calories and had reduced insulin sensitivity after use of the nasal spray. The randomized, placebo-controlled study, conducted by researchers from Harvard Medical School, involved 25 men, half of whom were normal weight and … [Read more...] about Study shows oxytocin nasal spray lowers calorie intake in men
Adamis announces positive Phase 1 results for its fluticasone/salmeterol DPI
Adamis Pharmaceuticals has announced that data from a Phase 1 PK study its APC-5000 fluticasone/salmeterol DPI, a generic carrier-free version of Advair Diskus, show less systemic exposure to both components compared to Advair. The open-label study compared 3 inhalations of APC-5000 to 3 inhalations of Advair Diskus in 16 healthy subjects over 4 treatment … [Read more...] about Adamis announces positive Phase 1 results for its fluticasone/salmeterol DPI
Sunovion initiates Phase 3 program for glycopyrrolate inhalation solution
A Phase 3 trial program of Sunovion Pharmaceutical's SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD has begun enrolling patients, the company announced. The program includes three studies expected to enroll about 2,340 COPD patients. SUN-101 is delivered using PARI's eFlow nebulizer system and, if approved, would be the … [Read more...] about Sunovion initiates Phase 3 program for glycopyrrolate inhalation solution