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Medical

PD study of Opiant’s intranasal nalmefene meets primary endpoint

According to Opiant Pharmaceuticals, a pharmacodynamic study of the company's OPNT003 intranasal nalmefene met its primary endpoint of non-inferiority compared to intranasal naloxone, with 3 mg of OPNT003 almost twice as effective as 4 mg of naloxone in reversing respiratory depression caused by a synthetic opioid at 5 minutes post dose. OPNT003, which is … [Read more...] about PD study of Opiant’s intranasal nalmefene meets primary endpoint

Virpax reports successful nose-to-brain delivery in a study of VRP324 dry powder CBD in a rodent model

Virpax Pharmaceuticals said that nasal delivery of its VRP324 dry powder cannabidiol in a rodent model produced high concentrations of CBD in the brain. In September 2021, Virpax announced that it had licensed Nanomerics’s molecular envelope technology (MET) for use with VRP324 and that Nanomerics was conducting preclinical studies. Virpax, which is developing the … [Read more...] about Virpax reports successful nose-to-brain delivery in a study of VRP324 dry powder CBD in a rodent model

Firebrick Pharma initiates Phase 2 trial of Nasodine povidone-iodine nasal spray for COVID-19

Australian pharmaceutical company Firebrick Pharma has announced the initiation of a Phase 2 trial of its Nasodine povidone-iodine nasal spray for the reduction of viral shedding in patients with COVID-19. According to Firebrick, a 2001 pilot study with 6 COVID-19 patients demonstrated that a single dose of Nasodine reduced viral shedding by almost 80% one hour post … [Read more...] about Firebrick Pharma initiates Phase 2 trial of Nasodine povidone-iodine nasal spray for COVID-19

Rensselaer and Albany Medical College get funding for development of pentosan polysulfate nasal spray against COVID-19

Researchers from Rensselaer Polytechnic Institute (RPI) and Albany Medical College will use a $500,000 grant from the New York State Biodefense Commercialization Fund for early development of a pentosan polysulfate (PPS) nasal spray for the prevention of respiratory infections, including COVID-19. PPS is currently approved in the US as an oral treatment for bladder … [Read more...] about Rensselaer and Albany Medical College get funding for development of pentosan polysulfate nasal spray against COVID-19

Positive Phase 1 results for TFF Pharmaceuticals’ dry powder niclosamide

TFF Pharmaceuticals announced that a Phase 1 SAD/MAD study of its dry powder niclosamide found that inhalation of the formulation was well tolerated at all doses evaluated and that data from the study suggest moving into a Phase 2 study with a twice daily 6 mg dose. The company, which recently said that the dry powder niclosamide completely inhibited the Omicron … [Read more...] about Positive Phase 1 results for TFF Pharmaceuticals’ dry powder niclosamide

Intranasal minibinder proteins effective against SARS-CoV-2 in preclinical studies

Researchers from Northwestern University, the University of Washington, and Washington University at St. Louis have published data demonstrating that select miniproteins neutralized SARS-CoV-2 better than mAbs currently in use for the treatment of COVID-19. The multivalent minibinder demonstrated potent activity against all variants of the virus tested, including … [Read more...] about Intranasal minibinder proteins effective against SARS-CoV-2 in preclinical studies

FDA allows additional MS patients in intranasal Foralumab expanded access program

Tiziana Life Sciences said that the FDA has issued a Study May Proceed letter allowing Brigham and Women’s Hospital (BWH) to treat an additional eight patients with secondary progressive multiple sclerosis (SPMS) with Tiziana's intranasal Foralumab under an Intermediate-Size Patient Population Expanded Access IND. The agency evaluated data from treatment of two … [Read more...] about FDA allows additional MS patients in intranasal Foralumab expanded access program

Respira initiates Phase 2b trial of RT234 inhaled vardenafil for PAH

Respira Therapeutics has announced the initiation of a Phase 2b trial of its RT234 dry powder vardenafil in patients with pulmonary arterial hypertension (PAH). The open label study will include two cohorts, with the first receiving a single 0.5 mg dose of RT234 via the Axial Oscillating Sphere inhaler and the second getting a 1 mg dose (2 x 0.5 mg). United … [Read more...] about Respira initiates Phase 2b trial of RT234 inhaled vardenafil for PAH

Phase 2b challenge study of intranasal PHAD for the prevention of H3N2 flu fails to meet primary endpoint

Revelation Biosciences has announced that a Phase 2b viral challenge study of its REVTx-99a intranasal phosphorylated hexaacylated disaccharide (PHAD) for the prevention of H3N2 influenza in healthy volunteers failed to meet its primary endpoint. The study, which enrolled 30 subjects aged 18 to 55, failed to demonstrate a statistically significant difference in viral … [Read more...] about Phase 2b challenge study of intranasal PHAD for the prevention of H3N2 flu fails to meet primary endpoint

FDA clears IND for Blue Lake intranasal RSV vaccine

CyanVac subsidiary Blue Lake Biotechnology is planning a Phase 1 trial of its BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) after receiving FDA clearance for its IND, CyanVac said. The Phase 1 trial will evaluate BLB-201 in two different cohorts, one aged 18-59 and the other aged 60-75. According to the company, preclinical studies of BLB-201 in … [Read more...] about FDA clears IND for Blue Lake intranasal RSV vaccine

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