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
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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
De Motu Cordis announces expansion of deal with Catalent for services related to development of DMC-IH1 epinephrine DPI
Australian pharma company De Motu Cordis (DMC), which is developing an epinephrine DPI for the treatment of anaphylaxis, announced that it has contracted with Catalent for product assembly, expanding a November 2022 deal with the CDMO that covered formulation and manufacturing. The extension of the deal will provide manufacturing and assembly services through a … [Read more...] about De Motu Cordis announces expansion of deal with Catalent for services related to development of DMC-IH1 epinephrine DPI
FDA issues CRL to Orexo’s resubmitted NDA for OX124 naloxone nasal powder
The FDA has issued a complete response letter to Orexo's NDA for OX124 intranasal dry powder naloxone for the reversal of opioid overdose, the company said. Orexo resubmitted the NDA in September 2023 after the agency rejected its first application due to concerns about the packaging process. The NDA had been initially submitted in early 2023. The FDA accepted the … [Read more...] about FDA issues CRL to Orexo’s resubmitted NDA for OX124 naloxone nasal powder