VistaGen Therapeutics has announced the initiation of the PALISADE-1 Phase 3 clinical trial of PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track designation for that indication in December 2019. In July 2020, the company announced details of the proposed trial, which is expected to enroll approximately 200 … [Read more...] about VistaGen initiates Phase 3 trial of PH94B aloradine nasal spray for social anxiety disorder
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Seelos announces positive Phase 2 results for SLS-002 intranasal racemic ketamine for suicidal ideation
Seelos Therapeutics said that the first part of a Phase 2 study of its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder (MDD) demonstrated significant reductions in suicidality and depression. Seelos had announced the initiation of the study in January 2021. The open label portion … [Read more...] about Seelos announces positive Phase 2 results for SLS-002 intranasal racemic ketamine for suicidal ideation
Pulmatrix says Cipla has breached a 2019 development agreement for Pulmazole intraconazole DPI
A month after regaining rights to PUR1800 and other inhaled narrow spectrum kinase inhibitors from Johnson & Johnson, Pulmatrix has announced that it may also reacquire the rights to its Pulmazole intraconazole DPI (PUR 1900). According to the company's business update, Pulmatrix recently notified Cipla that Cipla breached a 2019 development and commercialization … [Read more...] about Pulmatrix says Cipla has breached a 2019 development agreement for Pulmazole intraconazole DPI
Ampio says trial of inhaled Ampion in COVID-19 patients demonstrates 78% reduction in all-cause mortality
Ampio Pharmaceuticals has announced that the final results from the AP-014 Phase 1 trial of inhaled Ampion in COVID-19 patients demonstrated a greater reduction in all-cause mortality than was seen in the preliminary results. In March 2021, Ampio reported that preliminary data from the trial showed a 62% reduction in all-cause mortality. After all patients completed … [Read more...] about Ampio says trial of inhaled Ampion in COVID-19 patients demonstrates 78% reduction in all-cause mortality
Phase 3 trial of ciclesonide MDI for the treatment of COVID-19 fails to meet primary endpoint
Covis Pharma said that a Phase 3 trial of Alvesco ciclesonide MDI for the treatment of COVID-19 in 400 patients who have not been hospitalized failed to meet its primary endpoint, which was freedom from COVID-19 symptoms for 24 continuous hours by Day 30. The difference in time to alleviation of patients' COVID-19 symptoms was 70.6% for the ciclesonide MDI and 63.5% … [Read more...] about Phase 3 trial of ciclesonide MDI for the treatment of COVID-19 fails to meet primary endpoint
Virpax says MMS019 nasal spray inhibits viral replication in pre-clinical study
Virpax Pharmaceuticals announced that a study of its MMS019 powder "masking spray" in mice demonstrated "a marked inhibition of viral replication in the mouse nasal passages" for mice infected with SARS-CoV-2 and then given MMS019 intranasally for 6 days. Virpax licensed MMS019 from Nanomerics in August 2020 and is developing the formulation for the prevention of … [Read more...] about Virpax says MMS019 nasal spray inhibits viral replication in pre-clinical study
Nasus Pharma says BE study demonstrates its intranasal dry powder naloxone is absorbed faster than Narcan nasal spray
Nasus Pharma said that a bioequivalence study of its FMXIN001 dry powder intranasal naloxone demonstrated that FMXIN001 was absorbed significantly faster than Emergent BioSolutions' Narcan naloxone nasal spray, with an AUC 163% of the Narcan AUC after 4 minutes, and continued to demonstrate higher levels of naloxone in the blood through the first hour post dosing. The … [Read more...] about Nasus Pharma says BE study demonstrates its intranasal dry powder naloxone is absorbed faster than Narcan nasal spray
Pulmatrix regains rights to its inhaled narrow spectrum kinase inhibitors from J&J
Johnson & Johnson has decided not to exercise an option acquired in a 2020 agreement with Pulmatrix for development and commercialization of Pulmatrix's portfolio of inhaled narrow spectrum kinase inhibitors (NSKIs), including PUR1800. J&J's Lung Cancer Initiative had been interested in developing the dry powder formulation for lung cancer … [Read more...] about Pulmatrix regains rights to its inhaled narrow spectrum kinase inhibitors from J&J
AIM ImmunoTech says early results from Phase 1 safety study of intranasal Ampligen are positive
AIM ImmunoTech has announced that it will definitely advance an intranasal formulation of its Ampligen rintatolimod into a Phase 2 trial after the initial dose tested in a Phase 1 study showed no safety problems. The company announced initiation of the Phase 1 study, which is set to enroll 40 healthy subjects, in March 2021. The Phase 1 study began with a 75 μg dose … [Read more...] about AIM ImmunoTech says early results from Phase 1 safety study of intranasal Ampligen are positive
Intravacc announces results of pre-clinical study of its intranasal COVID-19 vaccine candidate
Intravacc has announced that a pre-clinical study of its intranasal outer membrane vesicle (OMV)-based recombinant spike protein (rSP) vaccine candidate against SARS-CoV-2 nose spray vaccine in hamsters and mice demonstrated complete protection. The company announced in June 2020 that it had partnered with Wageningen Bioveterinary Research and Utrecht University to … [Read more...] about Intravacc announces results of pre-clinical study of its intranasal COVID-19 vaccine candidate