InCarda Therapeutics has announced the completion of an oversubscribed $42 million Series B financing that will fund a Phase 2 study of InRhythm inhaled flecainide for the treatment of recent-onset paroxysmal atrial fibrillation (PAF). The financing round was led by Sofinnova and HealthCap, both new investors along with Deerfield Management. In 2015, InCarda raised … [Read more...] about InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide
Medical
Acerus Pharmaceuticals initiates Phase 1 study of intranasal cannabis oil
Acerus Pharmaceuticals has announced the initiation of a Phase 1 clinical trial of an intranasal formulation of cannabis oil, which the company said is "a preliminary step in a broader strategy focused on identifying additional applications for Acerus’ proprietary nasal delivery technology, including for prescription medical marijuana." The company has developed … [Read more...] about Acerus Pharmaceuticals initiates Phase 1 study of intranasal cannabis oil
Positive Phase 2b results for both Oyster Point nasal sprays for dry eye disease
Oyster Point Pharma has announced that separate Phase 2b studies of its OC-01 and OC-02 nicotine acetylcholine receptor (nAChR) agonist nasal sprays for the treatment of dry eye disease both showed improvement in dry eye symptoms for patients using the nasal sprays. Positive results for a previous Phase 2b trial of OC-2 were announced in July 2018. Oyster Point … [Read more...] about Positive Phase 2b results for both Oyster Point nasal sprays for dry eye disease
Biohaven Pharmaceutical initiates Phase 1 study of intranasal migraine candidate
Biohaven Pharmaceutical said that it has initiated a Phase 1 trial of its BHV-3500, an intranasal calcitonin gene-related peptide (CGRP) receptor antagonist delivered via the Aptar Pharma Unit Dose System after the FDA approved its IND. The trial will evaluate various doses of BHV-3500, which the company is developing for the treatment of migraine.The company … [Read more...] about Biohaven Pharmaceutical initiates Phase 1 study of intranasal migraine candidate
Positive Phase 1 results for Auris Medical’s intranasal betahistine
Auris Medical has announced results from a second Phase 1 study of its intranasal betahistine in 72 healthy volunteers that demonstrated superior bioavailability compared to oral betahistine for 4 doses of the nasal formulation, with plasma exposure up to 29 times higher. Earlier this year, Auris announced results from an earlier Phase 1 study and a pre-clinical … [Read more...] about Positive Phase 1 results for Auris Medical’s intranasal betahistine
Group developing inhaled antisense therapy for IPF gets funding through EuroNanoMed3
Secarna Pharmaceuticals has announced that the Inhaled Nanocarriers with Antisense Therapy for lung fibrosis (INAT) project has received a 3-year grant to fund from the ERA-Net Cofund EuroNanoMed3, part of the EC's Horizon 2020 Framework Program for Research and Innovation. Secarna is part of a consortium for INAT that includes French, German, and Belgian universities … [Read more...] about Group developing inhaled antisense therapy for IPF gets funding through EuroNanoMed3
Senzer reports data from PK study of inhaled dronabinol
According to Senzer, a PK study conducted by Insys Therapeutics found that a 0.35 mg dose of dronabinol delivered by Senzer's Voke inhaler achieved a similar maximum concentration as a 5.0 mg dose of Marinol oral dronabinol, with the inhaled dose reaching Cmax in 2 minutes compared to almost 2 hours for the oral dose. Insys acquired US rights to the Voke inhaler … [Read more...] about Senzer reports data from PK study of inhaled dronabinol
Phase 3 trial of intranasal esketamine fails to meet primary endpoint
Just weeks after Janssen announced that it had submitted an NDA for its intranasal esketamine for the treatment of depression, the company has presented data from a Phase 3 trial of the nasal spray that failed to meet its primary endpoint. Positive results from a previous Phase 3 study were published in May 2018. The new data from a study that enrolled 346 adults … [Read more...] about Phase 3 trial of intranasal esketamine fails to meet primary endpoint
Impel initiates Phase 1 trial of INP105 intranasal olanzapine
Impel NeuroPharma said that the first subject has been dosed in a Phase 1 study of INP105 intranasal dry powder olanzapine, which the company is developing for the treatment of acute agitation in bipolar I disorder and schizophrenia. The "SNAP 101" PK/PD trial will compare 3 doses of INP105 to 5 mg and 10 mg doses of intramuscular Zyprexa and to 10 mg of orally … [Read more...] about Impel initiates Phase 1 trial of INP105 intranasal olanzapine
Disappointing results for Phase 3b study of Bevespi Aerosphere
AstraZeneca has announced that the Phase 3b AERISTO trial of Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for moderate to very severe COPD failed to meet 2 out of 3 of its primary endpoints, including non-inferiority to umeclidinium/vilanterol on trough FEV1 and superiority on peak FEV1. Bevespi Aerosphere did demonstrate non-inferiority on peak … [Read more...] about Disappointing results for Phase 3b study of Bevespi Aerosphere