Qnovia (formerly Respira Technologies) has announced results from a Phase 1 trial of its QN-01 inhaled nicotine replacement therapy, which is based on the company's RespiRx vibrating mesh nebulizer platform. In September 2022, the company announced that it had raised $17 million for development of the nicotine replacement product. The Phase 1 PK study enrolled 12 … [Read more...] about Qnovia reports results from Phase 1 trial of QN-01 inhaled nicotine replacement therapy
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Ethris gets approval for Phase 1 trial of ETH47 inhaled mRNA
According to Ethris, a clinical trial authorization (CTA) that the company submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2023 has been approved, and Ethris expects to initiate a Phase 1 clinical trial of its ETH47 inhaled mRNA in healthy participants before the end of the year. The company is developing ETH47 as for the … [Read more...] about Ethris gets approval for Phase 1 trial of ETH47 inhaled mRNA
US Army to evaluate Seelos’s SLS-002 intranasal racemic ketamine for the treatment of PTSD
According to Seelos Therapeutics, the US Army Medical Research and Development Command will include the company's SLS-002 intranasal racemic ketamine in an adaptive platform trial of therapies for post-traumatic stress disorder (PTSD) in soldiers and veterans. The Phase 2 Department of Defense PTSD Adaptive Platform Trial (NCT05422612), which is expected to be … [Read more...] about US Army to evaluate Seelos’s SLS-002 intranasal racemic ketamine for the treatment of PTSD
GSK announces upcoming Phase 3 trials of HFA 152a version of Ventolin salbutamol (albuterol) MDI
GSK has announced that data generated from recently early stage trials support advancing a reformulated version of its Ventolin salbutamol (albuterol) MDI using HFA 152a as the propellant into Phase 3 trials. The company said that it expects to initiate those studies in the first half of 2024 with plans to file regulatory submissions for the reformulated product in … [Read more...] about GSK announces upcoming Phase 3 trials of HFA 152a version of Ventolin salbutamol (albuterol) MDI
Viatris and Theravance Biopharma say Chinese Phase 3 trial of Yupelri revefenacin inhalation solution met its primary endpoint
Viatris and Theravance Biopharma say that a Phase 3 trial of Yupelri revefenacin inhalation solution for the treatment of COPD conducted in China met its primary endpoint and that Viatris expects to file a marketing application for Yupelri in China next year. Yupelri has been approved for the treatment of COPD in the US since 2018. In 2015, Viatris (then Mylan) … [Read more...] about Viatris and Theravance Biopharma say Chinese Phase 3 trial of Yupelri revefenacin inhalation solution met its primary endpoint
Milestone says Phase 2 study of etripamil nasal spray in AFib-RVR met its primary endpoint
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
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