According to Levo Therapeutics, the Phase 3 CARE-PWS (CARbetocin Efficacy and Safety Study in PWS) trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) has begun to enroll patients. Levo acquired the rights to the intranasal carbetocin from Ferring Pharmaceuticals in 2017 and announced in June 2018 that it planned to restart the … [Read more...] about Levo Therapeutics initiates Phase 3 study of intranasal carbetocin for Prader-Willi Syndrome
Medical
Acerus announces results from Phase 1 study of intranasal cannabis oil formulation
Acerus Pharmaceuticals said that a Phase 1 trial of its intranasal formulation of tetrahydrocannabinol-rich cannabis oil in 12 healthy volunteers demonstrated that the bioavailability of TCH from the nasal formulation was 2.2 times better than previously reported bioavailability data for oral dronabinol. Average Tmax was found to be 7 hours after administration. … [Read more...] about Acerus announces results from Phase 1 study of intranasal cannabis oil formulation
Tiziana initiates Phase 1 trial of intranasal foralumab
Tiziana Life Sciences has announced that the FDA approved the company's IND for intranasal foralumab human anti-CD3 antibody, and a Phase 1 clinical trial has begun. Tiziana licensed foralumab from Novimmune in 2014 and is developing the nasal formulation for the treatment of neurodegenerative diseases such as multiple sclerosis. The dose escalating trial, … [Read more...] about Tiziana initiates Phase 1 trial of intranasal foralumab
Phase 1 study of Novus Therapeutics’ OP0201 intranasal surfactant gets underway
Novus Therapeutics said that it has initiated a Phase 1 clinical trial of OP0201, an intranasal surfactant that the company is developing for the treatment of otitis media. The 2-week study will evaluate daily administration of 30 mg and 60 mg doses of OP0201, delivered intranasally via MDI, in 30 healthy adults. Earlier this year, the company announced that it had … [Read more...] about Phase 1 study of Novus Therapeutics’ OP0201 intranasal surfactant gets underway
Theravance initiates Phase 1 trial of TD-8236 inhaled JAK inhibitor
According to Theravance Biopharma, the first subject has been dosed in a Phase 1 clinical trial of TD-8236, a JAK inhibitor that the company is developing as a DPI for the potential treatment of asthma, COPD, and other respiratory diseases. The company said that in preclinical studies, TD-8236 has demonstrated inhibition of JAK/STAT cytokines in disease relevant … [Read more...] about Theravance initiates Phase 1 trial of TD-8236 inhaled JAK inhibitor
Phase 3 trial of VR475 inhalation suspension fails to meet primary endpoint, Vectura discontinues development
Vectura has announced that a Phase 3 study of VR475 budesonide inhalation suspension for the treatment of severe uncontrolled asthma in adult and adolescent patients failed to meet its primary endpoint. As a result, the company said that it would discontinue development of VR475 (formerly known as Favolir), which it acquired when it acquired Activaero in … [Read more...] about Phase 3 trial of VR475 inhalation suspension fails to meet primary endpoint, Vectura discontinues development
Pulmatrix announces plans for Phase 2 study of Pulmazole itraconazole DPI
Pulmatrix said that based on final results from a Phase 1/1b study of its Pulmazole (PUR1900) itraconazole DPI, which it is developing for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients, the company now plans to begin a Phase 2 trial by the end of the year. The company previously reported top line data from the study showing … [Read more...] about Pulmatrix announces plans for Phase 2 study of Pulmazole itraconazole DPI
InCarda Therapeutics raises $42 million, initiates Phase 2 trial of inhaled flecainide
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
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