According to US-based ARS Pharmaceuticals, the company has raised $20 million in Series C financing for clinical development of its ARS-1 epinephrine nasal spray for the treatment of anaphylaxis. The financing round was led by Deerfield Management. ARS said that it has submitted an IND for the intranasal epinephrine, which incorporates Aegis Therapeutics' Intravail … [Read more...] about ARS Pharmaceuticals raises $20 million for clinical development of epinephrine nasal spray
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Verona initiates Phase 2 trial of RPL554 DPI for COPD
Verona Pharma said that it has initiated a Phase 2 clinical trial of its RPL554 PDE3/PDE4 inhibitor DPI. The study is expected to enroll 36 patients with moderate to severe COPD and will evaluate PK, efficacy, and safety. Verona is developing RPL554 as nebulized, DPI, and MDI formulations for various indications, including COPD, asthma, and cystic fibrosis. … [Read more...] about Verona initiates Phase 2 trial of RPL554 DPI for COPD
Insys says it plans NDA submissions for two nasal sprays in 2019
Insys Therapeutics says that it plans NDA submissions for both its naloxone and epinephrine nasal sprays in 2019. The company also noted the potential of regulatory submission for its inhaled dronabinol in the next few years. According to Insys, a PK study of the naloxone nasal spray "showed a distinctive profile for the . . . nasal spray product candidate in … [Read more...] about Insys says it plans NDA submissions for two nasal sprays in 2019
Levo Therapeutics initiates Phase 3 study of intranasal carbetocin for Prader-Willi Syndrome
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
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