Avalyn Pharma has initiated a Phase 1b SAD/MAD trial of its AP02 inhaled nintedanib delivered via the PARI eFlow nebulizer in healthy adults, the company said. Avalyn is developing AP02, along with AP01 inhaled pirfenidone, for the treatment of pulmonary fibrosis. In September 2023, the company announced that it had raised $175 million for continued development of … [Read more...] about Avalyn initiates Phase 1b study of APO2 inhaled nintedanib
Medical
Oragenics says pre-clinical study demonstrated that ONP-002 intranasal dry powder likely has a large cardiac safety margin
Oragenics announced that a GLP human Ether-à-go-go-Related Gene study conducted by Charles River Laboratories found that ONP-002, an intranasal neurosteroid, would likely not cause heart arrhythmias. ONP-002 is a new chemical entity formulated as a dry powder and delivered via a breath-activated nasal delivery device. The nasal powder is in development for the … [Read more...] about Oragenics says pre-clinical study demonstrated that ONP-002 intranasal dry powder likely has a large cardiac safety margin
Nasus Pharma says its FMXIN002 intranasal dry powder epinephrine demonstrated 5 years stability
According to Nasus Pharma, a stability study of the company's FMXIN002 nasal epinephrine powder demonstrated full stability for the formulation and device over 5 years of storage at 15 to 25℃. The company said that at 5 years, the epinephrine level was at 97.5%, with degradation products at 0.37%. Nasus noted that a previous stability test at 40℃ and 75% humidity … [Read more...] about Nasus Pharma says its FMXIN002 intranasal dry powder epinephrine demonstrated 5 years stability
NeOnc initiates Phase 2 trial of NEO100 intranasal perillyl alcohol in patients with high-grade meningiomas
NeOnc Technologies has announced the initiation of a Phase 2 trial of NEO100 intranasal perillyl alcohol in patients with tumors of the membranes surrounding the brain and/or spinal cord. A Phase 2 trial of the intranasal formulation in patients with grade 4 gliomas was initiated in May 2016 and recently expanded to include patients with a type of astrocytoma. Two … [Read more...] about NeOnc initiates Phase 2 trial of NEO100 intranasal perillyl alcohol in patients with high-grade meningiomas
Emergent BioSolutions’ Narcan naloxone nasal spray gets shelf-life extension in Canada
According to Emergent BioSolutions, the shelf life for newly manufactured Narcan naloxone nasal spray has been extended to 48 months; the previous shelf life was 36 months. Narcan has been approved for the reversal of opioid overdose in Canada since October 2016. Emergent Senior VP, Head of Products Business, Paul Williams commented, “Helping to save lives from … [Read more...] about Emergent BioSolutions’ Narcan naloxone nasal spray gets shelf-life extension in Canada
FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
According to NeOnc Technologies, the FDA has approved an expansion of an ongoing Phase 2a trial of the company's NEO100 intranasal perillyl alcohol to include patients with recurrent grade 3 astrocytoma with isocitrate dehydrogenase 1 (IDH1) mutation. NeOnc announced the initiation of the trial, which initially focused on treatment of grade 4 gliomas, in May 2016. The … [Read more...] about FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
UTMB researchers publish preclinical data on intranasal mAb to prevent Tau accumulation in the brain
The University of Texas Medical Branch announced publication of an article in Science Translational Medicine by UTMB researchers who are developing an intranasal toxic tau conformation–specific monoclonal antibody-2 (TTCM2) to prevent the accumulation of tau protein in the brain. The article describes successful intranasal delivery of TTCM2 loaded in micelles to the … [Read more...] about UTMB researchers publish preclinical data on intranasal mAb to prevent Tau accumulation in the brain
Tiziana says the FDA has approved use of intranasal foralumab in Alzheimer’s patients under an expanded access IND
Tiziana Life Sciences announced that it will dose a patient with moderate Alzheimer’s disease with intranasal foralumab under an expanded access IND. The company previously used the expanded access program to provide intranasal foralumab to multiple sclerosis patients at Brigham and Women’s Hospital and for home use before initiating a Phase 2a trial of foralumab for … [Read more...] about Tiziana says the FDA has approved use of intranasal foralumab in Alzheimer’s patients under an expanded access IND
Phase 3 IMPALA-2 trial of Savara’s inhaled mogramostim in aPAP patients meets primary endpoint
Savara has announced that the Phase 3 IMPALA-2 trial of molgramostim nebulized recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with autoimmune pulmonary alveolar proteinosis (aPAP) met its primary endpoint, achieving statistically significant change in percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) … [Read more...] about Phase 3 IMPALA-2 trial of Savara’s inhaled mogramostim in aPAP patients meets primary endpoint
MannKind says Phase 4 INHALE-3 study of Afrezza insulin DPI met its primary endpoint
MannKind Corporation announced that the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics met its primary endpoint, with 30% of participants using Afrezza achieving an HbA1c level of less than 7% at 17 weeks compared to 17% of the usual care group. The company, which announced some data from the … [Read more...] about MannKind says Phase 4 INHALE-3 study of Afrezza insulin DPI met its primary endpoint