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
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FDA approves ARS Pharmaceutical’s Neffy intranasal epinephrine for the treatment of anaphylaxis
The FDA has approved ARS Pharmaceutical's NDA for Neffy epinephrine nasal spray for the treatment of Type 1 allergic reactions, including anaphylaxis, in patients who weigh 30 kg or greater. In response, ARS Pharma announced that the product should be available in the US within 8 weeks and also said that it plans to submit an sNDA seeking approval for the use of Neffy … [Read more...] about FDA approves ARS Pharmaceutical’s Neffy intranasal epinephrine for the treatment of anaphylaxis
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
Bespak joins IPAC
According to Bespak, the company has joined the International Pharmaceutical Aerosol Consortium (IPAC), which is the parent organization of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). Earlier this year, Bespak spun out of Recipharm, which joined IPAC-RS as a member in 2022. Bespak will be represented on the IPAC board … [Read more...] about Bespak joins IPAC
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
US Precision Medicine and MicroNeb announce agreement for use of nebulizer technology for delivery of inhaled antitumor drug
A Florida-based company called MicroNeb and a privately-held biopharma company called US Precision Medicine (USPM) say that they have signed a memorandum of understanding allowing USPM to use MicroNeb nebulizer technology for delivery of an inhaled cancer drug. The MicroNeb web site currently does not provide images, data, or specific details related to any handheld … [Read more...] about US Precision Medicine and MicroNeb announce agreement for use of nebulizer technology for delivery of inhaled antitumor drug
Tiziana’s intranasal foralumab for the treatment of non-active secondary progressive MS gets Fast Track designation
The FDA has granted Fast Track designation to Tiziana Life Sciences' intranasal foralumab, an anti-CD3 monoclonal antibody, for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS), the company said. Tiziana is also developing intranasal foralumab for the treatment of Alzheimer's disease and has announced plans to develop the nasal … [Read more...] about Tiziana’s intranasal foralumab for the treatment of non-active secondary progressive MS gets Fast Track designation
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
J&J submits sNDA for Spravato esketamine nasal spray as a monotherapy for treatment-resistant depression
Johnson & Johnson said that it has submitted an sNDA to the FDA for the use of Spravato esketamine CIII nasal spray as a monotherapy for the treatment of treatment-resistant depression. In 2019, the FDA approved an NDA submitted by J&J subsidiary Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) for the use of Spravato with an oral … [Read more...] about J&J submits sNDA for Spravato esketamine nasal spray as a monotherapy for treatment-resistant depression