OptiNose has announced results of a randomized, single-dose, four-way cross-over PK study demonstrating that 20% less of its intranasal dry powder sumatriptan product delivered into the nose than Imitrex nasal spray resulted in over 60% more sumatriptan in the blood in the first 15 minutes. The 16 mg dose of the Optinose product also resulted in over 30% more in … [Read more...] about Study shows better absorption for dry powder intranasal sumatriptan than nasal or oral Imitrex
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Microdose announces completion of Phase 1 studies for inhaled RSV treatment
MicroDose Therapeutx has completed the Phase 1 clinical program for its inhaled antiviral fusion inhibitor MDT-637 for the treatment of respiratory syncytial virus infection and plans to present data from the three studies at the upcoming International Respiratory Syncytial Virus Symposium. The company announced completion of the first two studies in April 2012. … [Read more...] about Microdose announces completion of Phase 1 studies for inhaled RSV treatment
Ablynx completes Phase 1 study of inhaled nanobody for RSV
Belgian biopharmaceutical company Ablynx has announced positive results from a Phase 1 of its ALX-0171 inhaled Nanobody for the treatment of respiratory syncytial virus (RSV) infections. According to the company, the study demonstrated the safety and tolerability of ALX-0171 delivered by nebulizer. The double-blind, randomized trial tested six dose levels ranging … [Read more...] about Ablynx completes Phase 1 study of inhaled nanobody for RSV
Pearl Therapeutics completes Phase 2b study of glycopyrrolate MDI
Pearl Therapeutics says that it has completed a Phase 2b dose-ranging study of its PT001 glycopyrrolate (GP) metered dose inhaler in patients with moderate-to-severe COPD. The randomized, double-blind study included 6 doses from 18 µg to 600 ng twice daily. According to Pearl, it will present data from its dose-ranging studies of PT001 at "appropriate medical … [Read more...] about Pearl Therapeutics completes Phase 2b study of glycopyrrolate MDI
Tiotropium plus olodaterol improve lung function in Phase 2 study
According to Boehringer Ingelheim, a combination of tiotropium and olodaterol delivered using the Respimat soft mist inhaler significantly improved 24-hour FEV1 in COPD patients compared to olodaterol monotherapy at all doses tested. The 4-week double-blind study with 232 COPD patients testing doses of tiotropium of 1.25, 2.5, and 5 μg with either 5 μg or 10 μg of … [Read more...] about Tiotropium plus olodaterol improve lung function in Phase 2 study
Rigel initiates Phase 2 study of inhaled SYK inhibitor for asthma
Rigel Pharmaceuticals says that it has begun a Phase 2 clinical study of its R343 nhaled SYK inhibitor that is being evaluated as a potential treatment for allergic asthma. The 8-week study, called SITAR (SYK Inhibition for Treatment of Asthma with R343), will compare two doses R343 and placebo in approximately 270 adult asthma patients and is expected to be completed … [Read more...] about Rigel initiates Phase 2 study of inhaled SYK inhibitor for asthma
Almirall opens Canadian affiliate, presents positive Phase 3 results for Eklira Genuair
Almirall has opened a new affiliate in Toronto, Canada. Having a presence in Canada will help the company roll out its recently approved aclidinium DPI for COPD, among other drugs, Almirall says. The company will co-market aclidinium as Tudorza Pressair with Forest Laboratories. In Europe, aclidinium bromide inhalers are being marketed as the Eklira Genuair and … [Read more...] about Almirall opens Canadian affiliate, presents positive Phase 3 results for Eklira Genuair
Study finds that inhaled budesonide for children reduces adult height
A study by the Childhood Asthma Management Program (CAMP) Research Group published online in the New England Journal of Medicine on September 3 finds that children who received 400 μg of inhaled budesonide daily for 4-6 years had a mean adult height 1.2 cm less than children who received placebo. The researchers obtained height measurements from 943 participants out … [Read more...] about Study finds that inhaled budesonide for children reduces adult height
FDA questions for Novartis about Tobi Podhaler prior to advisory committee meeting
The FDA briefing materials for the September 5, 2012 meeting of the Anti-Infective Drugs Advisory Committee, which will consider the use of Novartis's Tobi tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa infections in cystic fibrosis patients, question both the efficacy and safety of the product, especially when compared to TOBI tobramycin … [Read more...] about FDA questions for Novartis about Tobi Podhaler prior to advisory committee meeting
Positive Phase 3 results for QVA 149, filings expected by the end of the year
According to Novartis, the latest Phase 3 study of the QVA149 indacaterol/glycopyrronium DPI demonstrated a significant reduction in exacerbations of moderate-to-severe COPD compared to the Seebri Breezhaler glycopyrronium bromide DPI alone. The company says that it plans to submit regulatory filings in Europe and Japan by the end of 2012 and in the US at the end of … [Read more...] about Positive Phase 3 results for QVA 149, filings expected by the end of the year