Firebrick Pharma announced that it has filed a Pediatric Investigation Plan (PIP) with the EMA's Pediatric committee for its Nasodine povidone-iodine nasal spray as the company plans to submit a marketing application for Nasodine by the end of 2023. In April 2022, Firebrick initiated a Phase 2 study of Nasodine for the treatment of COVID-19. A Phase 3 trial of … [Read more...] about Firebrick Pharma files Pediatric Investigation Plan for Nasodine povidone-iodine nasal spray
Medical
Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT
Beckley Psytech said that the FDA has approved the company's IND for a Phase 2b study comparing 2 doses of BPL–003 intranasal dry powder synthetic 5-MeO-DMT (mebufotenin) in patients with treatment-resistant depression. According to Beckley Psytech, the proposed Phase 2b study, which is expected to be initiated in the first half of this year, is the first ever … [Read more...] about Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT
AAHI gets $3 million for development of antiviral nasal spray
The non-profit Access to Advanced Health Institute (formerly the Infectious Disease Research Institute) said that it has received an award of up to $3 million for development of a prototype antiviral nasal spray from the US Department of Defense (D0D). The news comes soon after AAHI announced that it had received an award of worth up to $9.9 million for development of … [Read more...] about AAHI gets $3 million for development of antiviral nasal spray
ENA Respiratory says interpretation of Phase 2a flu challenge study of INNA-051 antiviral nasal spray was “complicated” by pre-existing immunity
ENA Respiratory announced that "an unexpectedly large proportion of participants having pre-existing immunity to the challenge strain" resulted in difficulties interpreting data from a Phase 2a flu challenge study of its INNA-051 pegylated TLR2/6 agonist nasal spray. According to the company, dosing with "a substantial dose of H3N2 influenza A virus" failed to infect … [Read more...] about ENA Respiratory says interpretation of Phase 2a flu challenge study of INNA-051 antiviral nasal spray was “complicated” by pre-existing immunity
NC State University researchers say inhaled hydrogel powder protects agains viral infections in animal models
Researchers at North Carolina State University have published an article in Nature Materials describing preclinical development of an inhalation powder they are calling "SHIELD" (Spherical Hydrogel Inhalation for Enhanced Lung Defense) that has demonstrated the ability to block viral lung infections in mouse and non-human primate models. Studies found that the SHIELD … [Read more...] about NC State University researchers say inhaled hydrogel powder protects agains viral infections in animal models
Tonix initiates Phase 2 trial of TNX-1900 intranasal oxytocin for the prevention of migraines
Tonix Pharmaceuticals has announced the initiation of the Phase 2 PREVENTION study of the company's TNX-1900 intranasal potentiated oxytocin for the prevention of migraine headaches. Tonix licensed TNX-1900 for the treatment of migraine from Trigemina in June 2020, and the company announced in November 2021 that the FDA had cleared an IND for a Phase 2 trial of … [Read more...] about Tonix initiates Phase 2 trial of TNX-1900 intranasal oxytocin for the prevention of migraines
Seelos Therapeutics initiates Phase 1 ethnobridging study of SLS-002 intranasal racemic ketamine
Seelos Therapeutics said that it has initiated a Phase 1 study comparing PK profiles of SLS-002 intranasal racemic ketamine in Japanese and non-Asian adults. In May 2021, the company announced positive Phase 2 results for SLS-002 for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. The intranasal ketamine is delivered … [Read more...] about Seelos Therapeutics initiates Phase 1 ethnobridging study of SLS-002 intranasal racemic ketamine
Pulmatrix initiates Phase 2b trial of PUR1900 itraconazole DPI in patients with ABPA and asthma
Pulmatrix has announced the initiation of a Phase 2b trial of its PUR1900 dry powder itraconazole in patients with allergic bronchopulmonary aspergillosis (ABPA) and asthma. In 2020, PUR1900 received fast track designation for that indication. Pulmatrix is partnered with Cipla subsidiary Cip Tec on development of the itraconazole DPI, which it has previously called … [Read more...] about Pulmatrix initiates Phase 2b trial of PUR1900 itraconazole DPI in patients with ABPA and asthma
Vistagen initiates Phase 1 trial of PH10 pherine nasal spray
Vistagen has announced the initiation of a Phase 1 clinical trial of its PH10 pherine nasal spray, which the company is developing for the treatment of major depressive disorder. In November 2022, the company announced that it had gotten the go-ahead for the Phase 1 trial of a new formulation of PH10 from the FDA, and the agency granted Fast Track designation to PH10 … [Read more...] about Vistagen initiates Phase 1 trial of PH10 pherine nasal spray
MannKind says it will advance MNKD-101 clofazimine inhalation suspension to Phase 2/3 study
MannKind Corporation said that it will advance MNKD-101 clofazimine to a Phase 2/3 study following positive results from a Phase 1 trial of the inhalation suspension delivered via jet nebulizer. The FDA has granted both orphan drug and QIDP designation to MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung infections. The company also announced the … [Read more...] about MannKind says it will advance MNKD-101 clofazimine inhalation suspension to Phase 2/3 study