Medical

Nasus Pharma said that in a second PK study of FMXIN002 intranasal dry powder epinephrine, 91% of subjects who received a 4 mg dose of the nasal formulation reached the clinical threshold for plasma exposure at 6 minutes post dose compared to 51% who received a dose of epinephrine from an EpiPen. The company reported results from the initial PK study in June 2021. … [Read more...] about Nasus reports results from second PK trial of FMXIN002 intranasal dry powder epinephrine

Acadia Pharmaceuticals said that it has initiated the Phase 3 COMPASS PWS study of ACP-101 carbetocin nasal spray for the treatment of excessive hunger in people with Prader-Willi syndrome (PWS). Acadia acquired the carbetocin nasal spray (formerly LV-101) when it acquired Levo Therapeutics in June 2022 and announced plans to develop ACP-101 for hyperphagia in PWS … [Read more...] about Acadia announces initiation of Phase 3 trial of ACP-101 carbetocin nasal spray for hyperphagia in PWS

Based on results from Part 2 of the Phase 1b/2a trial, BiomX said that it plans to advance its BX004 nebulized phage cocktail for the treatment of chronic P. aeruginosa lung infections in cystic fibrosis patients into a Phase 2b/3 trial "subject to regulatory feedback and availability of sufficient funding." The study data demonstrated limited efficacy, with culture … [Read more...] about BiomX says it plans to move forward with development of BX004 inhaled phage cocktail based on data from second half of Phase 1b/2a trial

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

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

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 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