MannKind Corporation announced that it recently presented initial data from a meal challenge that was part of the Phase 4 INHALE-3 trial of Afrezza insulin DPI plus basal insulin injections versus standard of care in Type 1 diabetics. Afrezza was approved by the FDA for the treatment of Type 1 and Type 2 diabetes in adults in 2014. The company said that it will … [Read more...] about MannKind presents data from Phase 4 trial of Afrezza inhaled insulin
Medical
Vast announces appointments in preparation for clinical development of ALX1 inhalation solution
Vast Therapeutics has announced the appointments of former Aradigm Senior Medical Director Paul Bruinenberg as Chief Medical Officer and Chris Polage as Medical Director in preparation for clinical development of its ALX1 inhalation solution. Bruinenberg was most recently Senior Medical Officer of the TB Alliance. In addition to his stint at Aradigm, Bruinenberg's … [Read more...] about Vast announces appointments in preparation for clinical development of ALX1 inhalation solution
UWA researchers get A$500,000 grant for development of Spritz-OM probiotic nasal spray for ear infections
Researchers at the University of Western Australia have received a A$500,000 grant from the CUREator biotech incubator for development of the Spritz-OM probiotic nasal spray for the prevention of ear infections in children. The grant was one of 5 awarded recently as part of an effort to fund projects aimed at minimizing antimicrobial resistance. According to the … [Read more...] about UWA researchers get A$500,000 grant for development of Spritz-OM probiotic nasal spray for ear infections
ARS Pharmaceuticals says Phase 2 trial of Neffy epinephrine nasal spray for urticaria met primary endpoints
ARS Pharmaceuticals announced that a Phase 2 trial of Neffy epinephrine nasal spray in patients with chronic spontaneous demonstrated that 1 mg and 2 mg doses of the intranasal epinephrine both produced statistically significant and clinically meaningful improvement in symptoms such as hives and itchy skin as soon as 5 minutes post dose. The inpatient study of Neffy, … [Read more...] about ARS Pharmaceuticals says Phase 2 trial of Neffy epinephrine nasal spray for urticaria met primary endpoints
ReCode Therapeutics initiates Phase 1 trial of RCT2100 inhaled mRNA therapy for CF
ReCode Therapeutics has announced the initiation of a Phase 1 safety and tolerability study of RCT2100 inhaled CFTR mRNA-based therapy, which the company is developing for cystic fibrosis patients who do not benefit from CFTR modulators. The study is expected to enroll 32 healthy adults and will evaluate a single dose of nebulized RCT2100 against placebo. According … [Read more...] about ReCode Therapeutics initiates Phase 1 trial of RCT2100 inhaled mRNA therapy for CF
ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
ARS Pharmaceuticals said that it intends to file a response to the September 2023 complete response letter to its NDA for Neffy epinephrine nasal spray “early in the second quarter of 2024,” with the response supported by data from a repeat dose study with nasal allergen challenge as requested by the FDA. According to ARS, topline results from the study, which … [Read more...] about ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
LTR Pharma initiates BE study of Spontan vardenafil nasal spray
LTR Pharma has announced the initiation of a bioequivalence study of its Spontan vardenafil nasal spray, which the company is developing for the treatment of erectile dysfunction. According to LTR, the study will compare a single dose of Spontan, 5 mg (2 sprays of 2.5 mg each) to 10 mg tablets of vardenafil in healthy adult males. The company says that it intends to … [Read more...] about LTR Pharma initiates BE study of Spontan vardenafil nasal spray
Apotex recalls two lots of APO-Mometasone nasal spray
Health Canada has announced that Apotex is recalling 2 lots of its mometasone nasal spray, a generic of Nasonex, due to possible contamination with Burkholderia cepacia complex. Lot TX5343 has an expiration date of September 2025, and lot TZ2586 has an expiration date in October 2025. APO-Mometasone nasal spray is approved in Canada for the treatment of allergies … [Read more...] about Apotex recalls two lots of APO-Mometasone nasal spray
SaNOtize initiates Phase 2 trial of its nitric oxide nasal spray in patients with sinusitis
SaNOtize has initiated a Phase 2 study of its nitric oxide nasal spray (NONS) for the treatment of recurrent acute rhinosinusitis, the company said. The trial is expected to enroll 186 patients who will receive either the NO nasal spray or placebo at the beginning of an episode of sinusitis, with time to symptom resolution as a primary endpoint. Previous trials of … [Read more...] about SaNOtize initiates Phase 2 trial of its nitric oxide nasal spray in patients with sinusitis
Krystal Biotech’s KB707 inhaled gene therapy for the treatment of lung tumors gets Fast Track designation
Krystal Biotech announced that inhaled KB707 gene therapy for the treatment of metastasized tumors in the lung that are not successfully treated with standard therapy has been granted Fast Track designation by the FDA. The FDA had previously granted Fast Track designation to intra-tumoral KB707 for the treatment of melanoma. In July 2023, Krystal announced that it … [Read more...] about Krystal Biotech’s KB707 inhaled gene therapy for the treatment of lung tumors gets Fast Track designation