Tonix Pharmaceuticals has provided updates on two formulations of its intranasal potentiated oxytocin. The company acquired the license for one of the formulations, TNX-1900 for the treatment of migraine, from Trigemina in June 2020. According to the announcement, Massachusetts General Hospital will conduct a Phase 2 trial of TNX-1900 for the treatment of binge … [Read more...] about Tonix Pharmaceuticals provides updates on TNX-1900 and TNX-2900 intranasal oxytocin
Medical
FDA lifts clinical hold on Penthrox methoxyflurane inhaler
According to Medical Developments International (MVP), the FDA has lifted a clinical hold on MVP's Penthrox methoxyflurane inhaler and, as a result, MVP is now preparing a Phase 3 trial of Penthrox for trauma pain that is expected to begin recruiting by the end of this year. The FDA issued the clinical hold letter to MVP in 2018, and MVP said in July 2019 that it … [Read more...] about FDA lifts clinical hold on Penthrox methoxyflurane inhaler
FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail
Sorrento Therapeutics announced that the FDA has given the company the okay to move ahead with a Phase 1 trial of its Covishield (STI-9199) intranasal antibody cocktail in healthy volunteers. According to Sorrento, in vitro and in vivo studies of STI-9199 have demonstrated that the antibody cocktail has activity against multiple variants of SARS-CoV-2, including three … [Read more...] about FDA clears Sorrento Therapeutics IND for trials of Covishield intranasal antibody cocktail
Intranasal COVID-19 booster elicits mucosal immunity and protects against infection in preclinical studies
BlueWillow Biologics and Medigen Vaccine Biologics Corporation (MVC) have announced that a preclinical study of their BW-1019 intranasal COVID-19 booster demonstrated that giving the nasal vaccine after intramuscular vaccination induced neutralizing antibodies and protected against disease in a hamster model. According to the companies, no detectable virus was found … [Read more...] about Intranasal COVID-19 booster elicits mucosal immunity and protects against infection in preclinical studies
Positive Phase 1 results for HRT’s naloxone nasal spray
Non-profit pharma company Harm Reduction Therapeutics (HRT) said that a Phase 1 clinical trial of its HRT001 naloxone nasal spray in healthy volunteers met its primary endpoint, demonstrating the bioequivalence of a 3.0 mg dose of HRT001 to a 0.4 mg dose of intramuscular naloxone at 2.5 and 5 minutes post dose. Funding for the study came from OxyContin manufacturer … [Read more...] about Positive Phase 1 results for HRT’s naloxone nasal spray
COPD Foundation partners with ENA Respiratory on development of pan-antiviral nasal spray
The COPD Foundation has partnered with ENA Respiratory for development of ENA's INNA-051 pegylated TLR2/6 agonist pan-antiviral nasal spray in patients with chronic lung disease, the company said. In June 2021, ENA Respiratory announced that it had raised A$32 million for development of INNA-051 and planned a Phase 1 trial. According to ENA, the Phase 1 study of … [Read more...] about COPD Foundation partners with ENA Respiratory on development of pan-antiviral nasal spray
TFF says in vitro studies demonstrate that its inhaled niclosamide may inhibit replication of the Omicron variant of SARS-CoV-2 better than currently available therapies
TFF Pharmaceuticals said that in vitro studies have demonstrated that the company's inhaled niclosamide candidate completely inhibits the Omicron variant of SARS-CoV-2 at a concentration of 1 μM, noting that both nirmatrelvir (Paxlovid) and molnupiravir have been shown to require concentrations of 2.5 μM or greater to completely inhibit Omicron. Enrollment in a … [Read more...] about TFF says in vitro studies demonstrate that its inhaled niclosamide may inhibit replication of the Omicron variant of SARS-CoV-2 better than currently available therapies
AstraZeneca partners with Honeywell on development of HFO-1234ze MDIs
AstraZeneca has announced a partnership with Honeywell for development of lower global warming potential MDIs using HFO-1234ze as a propellant. The company said that Breztri budesonide/ glycopyrronium/ formoterol fumarate is the first product it plans to convert to HFO-1234ze and that a Phase 1 trial of an HFO 1234ze formulation of budesonide/ glycopyrronium/ … [Read more...] about AstraZeneca partners with Honeywell on development of HFO-1234ze MDIs
Armata Pharmaceuticals announces plans for Phase 2 trial of AP-PA02 in NCFB
According to Armata Pharmaceuticals, the FDA has cleared the company's IND for a clinical trial of AP-PA02, an inhaled phage cocktail, in non-cystic fibrosis bronchiectasis (NCFB), and the company plans to initiate a Phase 2 trial of AP-PA02 in NCFB patients this year. AP-PA02 is already in clinical development for the treatment of lung infections in cystic … [Read more...] about Armata Pharmaceuticals announces plans for Phase 2 trial of AP-PA02 in NCFB
Virpax reports positive preclinical toxicology data for Envelta intranasal enkephalin
Virpax Pharmaceuticals said that preclinical studies of the company's Envelta (NES100) enkephalin nasal spray have not identified any toxicology issues in either rats or dogs. The company said that the results support further development of Envelta nasal spray for the treatment of pain, including cancer pain. In February 2021, Virpax announced that pre-clinical … [Read more...] about Virpax reports positive preclinical toxicology data for Envelta intranasal enkephalin