Opiant Pharmaceuticals has announced that, based on feedback from the FDA and positive data from a Phase I clinical study, the company plans to pursue a 505(b)(2) development path for its OPNT003 intranasal nalmefene for the treatment of opioid overdose. OPNT003 is formulated using Aegis Therapeutics' Intravail absorption enhancer, which Opiant licensed in 2017. … [Read more...] about Opiant Pharmaceuticals developing intranasal nalmefene for the treatment of opioid overdose
Medical
Savara’s IND for Moldgradex study approved
According to Savara, the FDA has approved an IND the company submitted for Molgradex, an inhaled molgramostim (recombinant human GM-CSF) formulation for the treatment of autoimmune pulmonary alveolar proteinosis (PAP), which the company filed in December 2017. The approval allows the company to enroll patients in the ongoing Phase 3 IMPALA study at sites in the … [Read more...] about Savara’s IND for Moldgradex study approved
Auris Medical announces pre-clinical and Phase 1 PK data for intranasal betahistine
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
Impel Neuropharma announces positive Phase 1 results for INP104 intranasal DHE
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
Trudell Medical study shows better asthma control for patients using AeroChamber Plus anti-static VHC
Trudell Medical International has announced publication of a retrospective study that found a 13% reduction in emergency room visits for patients using a metered dose inhaler with the company's AeroChamber Plus Flow-Vu Anti-Static valved holding chamber (VHC) compared to patients using non-anti-static holding chambers. The study, published in Pulmonary Therapy in … [Read more...] about Trudell Medical study shows better asthma control for patients using AeroChamber Plus anti-static VHC
In Phase 3 trial, AstraZeneca’s PT010 triple combination MDI meets 6 out of 7 primary endpoints
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 announces positive results from Phase 1 trial of LIQ861 trepostinil DPI
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
Pulmatrix announces Phase 1/1b study of Pulmazole inhaled intraconazole
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 announces Phase 1/2 study of Immunose Flu vaccine
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
FLUIDDA announces research collaboration with UCSF
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