Milestone Pharmaceuticals has published data from the Phase 2 ReVeRA trial of etripamil nasal spray in patients experiencing atrial fibrillation with rapid ventricular rate (AFib-RVR) that the company says "support further development of self-administered etripamil for the treatment of AFib-RVR." The article appeared in the journal Circulation: Arrhythmia and … [Read more...] about Milestone says Phase 2 study of etripamil nasal spray in AFib-RVR met its primary endpoint
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Inhalon Biopharma licenses human metapneumovirus antibodies for inhaled delivery
Inhalon Biopharma announced that it has licensed human metapneumovirus (hMPV) antibodies from the University of Georgia and intends to develop inhaled hMPV antibodies for the treatment of hMPV respiratory infections. According to the company's website, its pipeline includes a candidate designated IN-003 against hMPV. Inhalon's pipeline of inhaled therapies based … [Read more...] about Inhalon Biopharma licenses human metapneumovirus antibodies for inhaled delivery
United Therapeutics initiates Phase 3 TETON PPF study of Tyvaso treprostinil inhalation solution in patients with progressive pulmonary fibrosis
United Therapeutics has announced the initiation of the 52-week TETON PPF trial, which will evaluate the efficacy of Tyvaso treprostinil inhalation solution in almost 700 patients with progressive pulmonary fibrosis (PPF). The company said that the effort to expand the use of Tyvaso to patients with PPF with or without pulmonary hypertension (PH) is based on data from … [Read more...] about United Therapeutics initiates Phase 3 TETON PPF study of Tyvaso treprostinil inhalation solution in patients with progressive pulmonary fibrosis
Defender announces that NASA will conduct 2 Phase 2 trials of DPI-386 intranasal scopolamine
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
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
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
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
Codagenix gets BARDA funding for Phase 2b trial of CoviLiv intranasal vaccine against COVID-19
According to Codagenix, the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) will provide up to $389 million to support a Phase 2b trial of CoviLiv live attenduated intranasal vaccine as a booster. Under the contract, the first tranche provided by BARDA will be $10 million. Codagenix is developing CoviLiv in … [Read more...] about Codagenix gets BARDA funding for Phase 2b trial of CoviLiv intranasal vaccine against COVID-19