According to Qnovia (formerly Respira Technologies), the FDA has cleared an IND submitted by the company for a trial of its QN-01 RespiRx nicotine inhaler, which the company is developing for smoking cessation. The company says that it plans to initiate the Phase 1 study, which is expected to enroll 24 smokers, by the end of the year. The trial will compare nicotine … [Read more...] about FDA clears Qnovia’s IND for Phase 1 study of QN-01 RespiRx inhaled nicotine
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Transpire Bio announces initiation of Phase 1 study of generic inhaler for asthma and COPD
Transpire Bio has announced the initiation of its clinical program for a generic inhaler for the treatment of asthma and COPD. The company did not specify which of its pipeline products has been advanced into Phase 1. According to Transpire Bio's web site, the company's pipeline includes both a DPI and an MDI for asthma/COPD in addition to a DPI and SMIs for COPD. … [Read more...] about Transpire Bio announces initiation of Phase 1 study of generic inhaler for asthma and COPD
InCarda says development of FlecIH-103 flecainide inhalation solution will continue despite early termination of Phase 3 trial
According to InCarda, data from the Phase 3 RESTORE-1 trial of FlecIH-103 flecainide inhalation solution for aroxysmal atrial fibrillation (PAF), which was initiated in July 2022, support continued development despite the early termination of the study due to disappointing efficacy and plasma concentrations. InCarda cites delivery problems with the jet nebulizer used … [Read more...] about InCarda says development of FlecIH-103 flecainide inhalation solution will continue despite early termination of Phase 3 trial
ARS launches Neffy nasal epinephrine nasal spray in the US
ARS Pharmaceuticals has launched Neffy epinephrine nasal spray in the US, the company said. In Auguest 2024, Neffy was approved by the FDA for the treatment of anaphylaxis in patients who weigh 30 kg or more. Earlier this month, ARS submitted an sNDA for a lower dose of Neffy for the treatment of anaphylaxis in children weighing 15 to 30 kg (33-66 lbs). European … [Read more...] about ARS launches Neffy nasal epinephrine nasal spray in the US
Fagron gets rights to use PureIMS’s Cyclops DPI with compounded inhalation powders in the Netherlands
PureIMS has announced that personalized medicine company Fagron has acquired exclusive rights to distribute PureIMS's Cyclops dry powder inhaler with compounded inhalation powders in the Netherlands. The Cyclops DPIs, which are pre-filled with drug, will be dispensed by compounding pharmacy Infinity Pharma. According to the announcement, the deal includes … [Read more...] about Fagron gets rights to use PureIMS’s Cyclops DPI with compounded inhalation powders in the Netherlands
Vistagen initiates Phase 3 PALISADE-4 trial of fasedienol nasal spray for social anxiety disorder
Vistagen has announced the initiation of the Phase 3 PALISADE-4 trial of fasedienol pherine nasal spray in people with social anxiety disorder (SAD). According to the company, the PALISADE-4 trial is similar to the PALISADE-3 trial, which was initiated earlier this year. Both of those studies have protocols that are similar to the PALISADE-2 trial, which the company … [Read more...] about Vistagen initiates Phase 3 PALISADE-4 trial of fasedienol nasal spray for social anxiety disorder
Iconovo reports positive feedback from the FDA regarding its ICOpre DPI and reacquisition of rights to the ICOone device
DPI developer Iconovo said that the FDA "has issued a positive guidance regarding the generic substitutability of the company's proprietary inhaler ICOpre with the original drug Breo Ellipta with respect to external design and operating principles" and indicated that the device is suitable for an ANDA for a generic of Breo Ellipta fluticasone furoate/vilanterol DPI. … [Read more...] about Iconovo reports positive feedback from the FDA regarding its ICOpre DPI and reacquisition of rights to the ICOone device
FDA approves FluMist intranasal flu vaccine for self-administration
The FDA and AstraZeneca are both touting the agency's approval of FluMist intranasal influenza vaccine for caregiver administration to children aged 2-17 and for self-administration by adults up to age 49. The agency agreed to review AstraZeneca's sBLA for the self-administration change in October 2023. FluMist will still be available for healthcare provider … [Read more...] about FDA approves FluMist intranasal flu vaccine for self-administration
FDA warns agains use of Green Pharmaceutical’s SnoreStop nasal spray due to microbial contamination
The FDA has advised California-based Green Pharmaceuticals to recall its SnoreStop nasal spray due to "significant microbial contamination in SnoreStop Nasal Spray lot number 2460" detected during an inspection in April 2024 and is warning customers not to use the product. The FDA notes that the homeopathic product is unapproved and that Green previously recalled a … [Read more...] about FDA warns agains use of Green Pharmaceutical’s SnoreStop nasal spray due to microbial contamination
Tiziana announces $4 million NIH grant for study of intranasal foralumab for Alzheimer’s disease
Tiziana Life Sciences announced that a study of the company's intranasal anti-CD3 mAb will be funded by a $4 million grant from the National Institutes of Health. In June 2024, the company said that the FDA had approved the use of intranasal foralumab in a patient with moderate Alzheimer’s disease under an expanded access IND. Tiziana said that it anticipates … [Read more...] about Tiziana announces $4 million NIH grant for study of intranasal foralumab for Alzheimer’s disease