Verona Pharma has initiated a Phase 2 trial of the MDI formulation of RPL554 ensifentrine in COPD patients, the company said. Verona recently announced the initiation of a Phase 2b study of nebulized ensifentrine and interim results from a Phase 2 study of the DPI formulation for COPD. The Phase 2 study of the MDI formulation is expected to enroll 36 patients with … [Read more...] about Verona Pharma initiates Phase 2 trial of RPL554 ensifentrine MDI
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Study shows ARS-1 intranasal epinephrine has similar PK profile to intramuscular epinephrine
ARS Pharmaceuticals has announced results from the EPI-04 clinical study demonstrating that the company's ARS-1 intranasal epinephrine spray has a pharmacokinetic profile that is similar to intramuscular epinephrine. ARS is developing ARS-1 for the treatment of anaphylaxis, and ARS-1 received Fast Track Designation for that indication earlier this year. The EPI-04 … [Read more...] about Study shows ARS-1 intranasal epinephrine has similar PK profile to intramuscular epinephrine
Phase 3 trial of QVM149 meets primary and secondary endpoints
Novartis has announced that the Phase 3 QUARTZ study met its primary and secondary endpoints, demonstrating that low dose QMF149 indacaterol/mometasone furoate delivered via the Breezhaler DPI produced statistically significant and clinically meaningful lung function and asthma control improvements compared to mometasone furoate alone in adult and adolescent patients … [Read more...] about Phase 3 trial of QVM149 meets primary and secondary endpoints
BlueWillow announces US patent for intranasal anthrax vaccine
According to BlueWillow Biologics, the University of Michigan has been issued US patent No. 10,138,279 which covers an intranasal anthrax vaccine formulated with BlueWillow's NanoVax adjuvant. BlueWillow (formerly NanoBio) is a spin out from the University of Michigan and has an exclusive license to the anthrax vaccine. The company said that its partner … [Read more...] about BlueWillow announces US patent for intranasal anthrax vaccine
According to Vectura and Sosei, Novartis has filed MAA for triple therapy DPI
Vectura Group and Sosei Group each said that they are owed $2.5 million milestone payments from Novartis after the EU accepted Novartis's MAA for its QVM149 indacaterol/glycopyrronium/mometasone furoate DPI for the treatment of asthma that is inadequately controlled. Vectura said that approval of the MAA would trigger an additional milestone payment of $5 million. … [Read more...] about According to Vectura and Sosei, Novartis has filed MAA for triple therapy DPI
Study finds as-needed budesonide/formoterol superior to as-needed albuterol (salbutamol) for reducing risk of severe exacerbations in mild asthma
A study published May 19, 2019 in the New England Journal of Medicine found that the Symbicort Turbuhaler budesonide/formoterol DPI demonstrated a greater than 50% reduction in the risk of asthma exacerbations in mild asthma patients compared to as-needed albuterol (salbutamol) alone. Compared to as-needed albuterol used in conjunction with maintenance budesonide, … [Read more...] about Study finds as-needed budesonide/formoterol superior to as-needed albuterol (salbutamol) for reducing risk of severe exacerbations in mild asthma
Respivant initiates Phase 2b study of RVT-1601 for IPF cough
Respivant Sciences has announced dosing of the first patient in the Phase 2b SCENIC trial of its RVT-1601 cromolyn sodium inhalation solution for the treatment of cough in idiopathic pulmonary fibrosis (IPF) patients. Respivant was spun off from Roivant in September 2018 specifically to develop RVT-1601. Roivant acquired the cromolyn sodium inhalation solution, … [Read more...] about Respivant initiates Phase 2b study of RVT-1601 for IPF cough
Phase 3 study of Ryaltris nasal spray for treatment of allergic rhinitis in pediatric patients met primary endpoint
Glenmark Pharmaceuticals recently said that a Phase 3 study comparing Ryaltris olopatadine hydrochloride to placebo in seasonal allergic rhinitis patients aged 6 up to 12 years achieved its primary endpoint. The 14-day study, which enrolled 446 patients, demonstrated a statistically significant improvement in average Reflective Total Nasal Symptom Score (rTNSS), with … [Read more...] about Phase 3 study of Ryaltris nasal spray for treatment of allergic rhinitis in pediatric patients met primary endpoint
Verona initiates Phase 2b study of nebulized ensifentrine for COPD
Verona Pharma said that it has initiated a Phase 2b dose-ranging study of RPL554 nebulized ensifentrine for the treatment of COPD, with results expected by the end of 2019. The company, which reported positive results from a Phase 2 study of an ensifetrine DPI in March 2019, said that it also expects to start a Phase 2 trial of an ensifetrine MDI for COPD this quarter … [Read more...] about Verona initiates Phase 2b study of nebulized ensifentrine for COPD
Phase 3 study of Trelegy Ellipta for the treatment of asthma meets primary endpoint
GlaxoSmithKline and Innoviva have announced that the Phase 3 CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) study comparing the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI to the Relvar/Breo Ellipta FF/VI DPI in patients with uncontrolled asthma met its primary endpoint. The CAPTAIN … [Read more...] about Phase 3 study of Trelegy Ellipta for the treatment of asthma meets primary endpoint