Medical

Auris Medical Holding has announced that a PK study of an intranasal betahistine formulation demonstrated 5-35 times higher bioavailability in dogs compared to oral betahistine, and a Phase 1 study showed 20-40 times higher bioavailability for the intranasal formulation compared to oral betahistine in humans. The company is developing AM-125 intranasal betahistine … [Read more...] about Auris Medical announces pre-clinical and Phase 1 PK data for intranasal betahistine

According to Impel NeuroPharma, a Phase 1 proof-of-concept trial of its INP104 intranasal dihydroergotamine (DHE) for the treatment of acute migraine headache demonstrated comparable bioavailability for INP104 to IV DHE and a statistically significant increase in Cmax and AUC compared to Migranal DHE nasal spray. INP104 was also well tolerated, the company … [Read more...] about Impel Neuropharma announces positive Phase 1 results for INP104 intranasal DHE

AstraZeneca has announced top-line results from the Phase 3 KRONOS trial of its PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of moderate to severe COPD. Compared to Bevespi Aerosphere glycopyrronium/formoterol fumarate, Symbicort Turbuhaler budesonide/formoterol fumarate, and PT009 budesonide/formoterol fumarate, PT010 demonstrated … [Read more...] about In Phase 3 trial, AstraZeneca’s PT010 triple combination MDI meets 6 out of 7 primary endpoints

Liquidia Technologies has presented preclinical and Phase 1 study results for its LIQ861 inhaled treprostinil for the treatment of pulmonary arterial hypertension at the Annual World Congress of the Pulmonary Vascular Research Institute (PVRI), noting that the data supported advancement of LIQ861 into the INSPIRE Phase 3 trial which was initiated earlier this month. … [Read more...] about Liquidia announces positive results from Phase 1 trial of LIQ861 trepostinil DPI

The UK Medicines and Healthcare Products Regulatory Agency has approved a Clinical Trial Application filed by Pulmatrix for a Phase 1/1b study of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients, the company said. In October 2017, Pulmatrix announced that PUR1900 received … [Read more...] about Pulmatrix announces Phase 1/1b study of Pulmazole inhaled intraconazole

Eurocine Vaccines has received authorization from the Swedish Medical Products Agency for a Phase 1/2 clinical study of its intranasal quadrivalent influenza vaccine Immunose Flu during the current flu season, the company said. Eurocine Vaccines also ran a Phase 1/2 study of Immunose Flu in 2016. Immunose Flu is based on the company's Endocine nasal vaccine … [Read more...] about Eurocine Vaccines announces Phase 1/2 study of Immunose Flu vaccine

Functional respiratory imaging specialist FLUIDDA has announced a new research collaboration with a team at the University of California, San Francisco led by Professor John Fahy that will use FLUIDDA technology "to understand the effects of pathologic mucus on lung function and on the deposition patterns of inhaled therapeutics." FLUIDDA CEO Jan De Backer said, … [Read more...] about FLUIDDA announces research collaboration with UCSF

A Phase 3 trial of Liquidia Technologies' LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) is underway, the company said. The study is expected to enroll a minimum of 100 PAH patients in the US, with topline data anticipated in 2019. LIQ861, a dry powder formulation based on Liquidia’s PRINT particle engineering technology, is one … [Read more...] about Liquidia announces initiation of Phase 3 trial of trepostinil DPI for PAH

Janssen Research & Development has published data from a Phase 2 study of its intranasal esketamine that demonstrate rapid improvement of symptoms in patients with treatment-resistant depression. The study was conducted from 2014-2015, and results were published in JAMA Psychiatry on December 27, 2017. The trial enrolled 126 patients diagnosed with major … [Read more...] about Janssen publishes results from Phase 2 trial of intranasal esketamine for depression