Medical

Codagenix has announced the initiation of a Phase 3 trial of its CoviLiv live-attenuated intranasal vaccine against COVID-19. The trial, which is being conducted in partnership with the Serum Institute of India, is part of the World Health Organization's Solidarity Trial Vaccines trial. The Phase 3 study is expected to enroll up to 20,000 healthy adults in countries … [Read more...] about Phase 3 trial of Codagenix’s CoviLiv intranasal vaccine against COVID-19 gets underway

According to Covis Pharma, the Phase 3 AVANT trial of Duaklir aclidinium bromide / formoterol and Eklira (Tudorza) aclidinium bromide DPIs demonstrated statistically significant change in FEV1 from baseline one hour post dose for Duaklir vs Eklira alone and vs formoterol alone, as well as for Eklira vs placebo. Covis acquired global rights to Duaklir and Eklira from … [Read more...] about Covis announces positive results from Phase 3 trial of Duaklir and Eklira in Asia

Atai Life Sciences announced that it has initiated a Phase 1 proof-of-concept trial of its INB-01, an excipient designed to cause gelling of liquid nasal sprays when the aerosol deposits in the nasal cavity. In July 2021, Atai said that it was launching a company called Innaris Bio to develop the sol-gel technology for use in intranasal CNS drug formulations in … [Read more...] about Atai Life Sciences initiates Phase 1 trial of INB-01 intranasal gelling excipient

According to Milestone Pharmaceuticals, the Phase 3 RAPID (formerly NODE 301b) trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) has met its primary endpoint, demonstrating that almost two thirds of patients using etripamil converted to sinus rhythm within half an hour while less than a third of patients using a placebo … [Read more...] about Phase 3 trial of Milestone’s etripamil nasal spray for PSVT meets primary endpoint

According to Orexo, a Phase 1 trial of OX640 nasal epinephrine powder demonstrated that each of 4 formulations evaluated was safe and well tolerated and achieved epinephrine plasma levels comparable to autoinjected intramuscular epinephrine (EpiPen). Each of the intranasal formulations also produced concentration-dependent changes in blood pressure and heart rate. The … [Read more...] about Positive Phase 1 results for Orexo’s OX640 intranasal epinephrine

Disappointing data from a Phase 1 study of intranasal delivery of AstraZeneca's ChAdOx1 nCoV-19 vaccine against COVID-19 led researchers from the University of Oxford to conclude that there is a "need for further development of nasal spray vaccines," the university said. The researchers reported the results in The Lancet's eBioMedicine. Intranasal delivery of the … [Read more...] about Intranasal delivery of AstraZeneca’s COVID-19 vaccine fails to elicit sufficient immune response in Phase 1 trial

United Therapeutics has announced the initiation of the Phase 3 TETON 2 trial of Tyvaso treprostinil inhalation solution in patients with idiopathic pulmonary fibrosis (IPF). In December 2020, the company announced that the FDA had granted orphan drug designation to treprostinil for the treatment of IPF and had cleared an IND for the Phase 3 TETON program. The TETON 1 … [Read more...] about United Therapeutics announces the initiation of a second Phase 3 trial of Tyvaso in IPF patients

Synairgen has announced that the Phase 2 ACTIV-2 trial of SNG001 inhaled interferon-beta-1a in non-hospitalized COVID-19 patients failed to show a statistically significant reduction in hospitalization, viral load, safety, or resolution of symptoms compared to placebo, but the study did demonstrate a relative reduction of 86% in hospitalization. Over the course of the … [Read more...] about Synairgen announces top-line data from Phase 2 ACTIV-2 trial of SNG001 nebulized interferon-beta-1a for mild-to-moderate COVID-19