Researchers at the United States National Aeronautics and Space Administration (NASA) will lead 2 Phase 2 studies of Defender Pharmaceuticals' DPI-386 scopolamine nasal gel for the prevention of motion sickness induced by sudden changes in gravitoinertial forces (g-transitions) such as those experienced by astronauts. The FDA recently accepted Defender's NDA for … [Read more...] about Defender announces that NASA will conduct 2 Phase 2 trials of DPI-386 intranasal scopolamine
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Milestone submits NDA for etripamil nasal spray for the treatment of PVST
Milestone Pharmaceuticals said that it has submitted an NDA for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and that the FDA has conditionally approved the proposed trade name "Cardamyst." The company said that it is continuing preparations for an anticipated commercial launch. According to Milestone, the clinical … [Read more...] about Milestone submits NDA for etripamil nasal spray for the treatment of PVST
Beckley Psytech initiates Phase 2b study of BPL-003 intranasal mebufotenin for treatment resistant depression
Beckley Psytech has announced the initiation of a Phase 2b trial of BPL-003 intranasal synthetic 5-MeO-DMT (mebufotenin) in people with moderate-to-severe treatment resistant depression. In February 2023, the company announced that the FDA approved an IND for the study. A Phase 2a trial of BPL-003 is still underway, Beckley said. The Phase 2b study is expected to … [Read more...] about Beckley Psytech initiates Phase 2b study of BPL-003 intranasal mebufotenin for treatment resistant depression
Qnovia partners with University of Virginia for development of inhaled antimicrobial peptides
Qnovia (formerly Respira Technologies) has announced a partnership with researchers at the University of Virginia (UVA) for the development of two new antimicrobial peptides for delivery via the company's RespiRx vibrating mesh nebulizer technology. The new candidates will be called QN-05, which will be developed for the treatment of pneumonia, and QN-06, for the … [Read more...] about Qnovia partners with University of Virginia for development of inhaled antimicrobial peptides
FDA okays home dosing of Tiziana’s intranasal foralumab for MS patients in expanded access program
According to Tiziana Life Sciences, the FDA is allowing patients with multiple sclerosis who are taking part in an expanded access program through Brigham and Women's Hospital to use intranasal foralumab at home instead of at the hospital. In April 2022, the company announced that the agency had agreed to allow the access program to expand to a total of 10 patients … [Read more...] about FDA okays home dosing of Tiziana’s intranasal foralumab for MS patients in expanded access program
Aculys says it will file NDA based on interim analysis of Japanese Phase 3 trial of NRL-1 (Valtoco) diazepam nasal spray
Aculys Pharma says that it plans to move ahead with submission of a marketing application to Japanese authorities based on interim data showing that a Japanese Phase 3 clinical study of NRL-1 diazepam nasal spray in epilepsy patients aged 6 to 17 met its primary efficacy endpoint. Aculys acquired development and commercialization rights to Neurelis's NRL-1 diazepam … [Read more...] about Aculys says it will file NDA based on interim analysis of Japanese Phase 3 trial of NRL-1 (Valtoco) diazepam nasal spray
Phase 2 trial of Cyrano’s intranasal theophylline for the treatment of post-viral hyposmia gets underway
Cyrano Therapeutics has announced the initiation of the Phase 2 FLAVOR trial of CYR-064 theophylline soft-mist nasal spray in patients who have lost their sense of smell following a viral infection. Cyrano announced plans for the Phase 2 trial in January 2023. The FLAVOR trial will compare the safety and tolerability of two doses of CYR-064 to placebo over a 6-month … [Read more...] about Phase 2 trial of Cyrano’s intranasal theophylline for the treatment of post-viral hyposmia gets underway
Akita Biosciences launches Profi antiviral nasal spray
Startup Akita Biosciences, newly launched by faculty members of Brigham & Women's Hospital to develop intranasal therapies, has announced the availability of its first nasal product. The company says that Profi prophylactic nasal spray is "a drug-free formulation composed predominantly of ingredients that have previously been used intranasally at doses higher than … [Read more...] about Akita Biosciences launches Profi antiviral nasal spray
NIAID will conduct study evaluating inhaled versus nasal delivery of Ocugen’s OCU500 vaccine against COVID-19
According to Ocugen, the US National Institute of Allergy and Infectious Diseases (NIAID) will conduct a study comparing the immune response generated by Ocugen's OCU500 vaccine candidate delivered via inhalation versus OCU500 delivered as a nasal spray. The research will be conducted as part of Project NextGen, which is expected to begin clinical trials early next … [Read more...] about NIAID will conduct study evaluating inhaled versus nasal delivery of Ocugen’s OCU500 vaccine against COVID-19
Oragenics to acquire Odyssey Health’s nasal delivery technology
Oragenics will acquire Odyssey Health's breath-powered intranasal delivery device and dry powder nasal formulations, in a deal that includes 8 million shares of Oragenics Series F preferred stock and a total of $1 million in cash, the companies said. The drugs included in the deal are Odyssey's OPN-002 for the treatment of mild traumatic brain injury and ONP-001 for … [Read more...] about Oragenics to acquire Odyssey Health’s nasal delivery technology