Medical

Ampio Pharmaceuticals announced that it plans to submit an expanded access protocol to the FDA to study the effects of a nebulized formulation of its Ampion anti-inflammatory biologic in patients with moderate to severe acute respiratory distress syndrome (ARDS) caused by COVID-19. The company said that it expects to evaluate the effectiveness of inhaled Ampion in … [Read more...] about Ampio takes steps toward testing nebulized Ampion anti-inflammatory biologic in COVID-19 patients

Biohaven Pharmaceutical has announced that it met with the FDA following completion of Phase 2 clinical trials of its intranasal vazegepant (BHV-3500) for the treatment of migraine and is ready to advance the 10 mg dose of the nasal spray into a Phase 3 trial. In December 2019, Biohaven reported topline data from a Phase 2/3 dose finding trial in which both 10 and 20 … [Read more...] about Biohaven’s intranasal vazegepant for migraine to advance into Phase 3 trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) have expedited approvals for a Phase 2 trial of Synairgen's SNG001 nebulized interferon-beta-1a for the treatment of COVID-19, the company said. According to the company, coronaviruses like SARS-CoV-2 have the ability to interfere with production of endogenous … [Read more...] about Synairgen announces trial of SNG001 inhaled interferon-beta-1a for COVID-19

Engage Therapeutics said that the Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of Staccato inhaled alprazolam in epilepsy patients has met its primary endpoint, terminating seizure activity within two minutes of dosing with no recurrence in 50 of 76 patients. Engage had announced the initiation of the study in April … [Read more...] about Engage Therapeutics reports positive results from Phase 2 study of Staccato alprazolam for epileptic seizures

Otitopic announced that it has held discussions with the FDA regarding a pivotal PK/PD study of its Asprihale aspirin dry powder inhaler and now expects to initiate the study in the fourth quarter of 2020. Results are expected by the end of 2021, the company said. Otitopic is developing Asprihale for the treatment of myocardial infarction and has indicated that it … [Read more...] about Otitopic announces planned PK/PD study of its Asprihale aspirin DPI

United Therapeutics has announced that the Phase 3 INCREASE study of Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) met its primary endpoint, demonstrating statistically significant improvement in six-minute walk distance (6MWD).  All secondary endpoints for the study were also … [Read more...] about Phase 3 trial of Tyvaso inhaled treprostinil in patients with PH-ILD meets primary endpoint

Breath Therapeutics, which was acquired by Zambon in July 2019, said that it has initiated two new trials of its liposomal cyclosporine A for inhalation (L-CsA-i) for the treatment of bronchiolitis obliterans syndrome (BOS). BOSTON-3 is open-label extension study of the Phase 3 BOSTON-1 and BOSTON-2 studies of L-CsA-i for the treatment of BOS after a lung transplant … [Read more...] about Breath Therapeutics initiates additional studies of inhaled liposomal cyclosporine A for bronchiolitis obliterans

Seurat Therapeutics has published data from studies of its intranasal IGF-1 in rat models for the treatment of migraine in the journal Brain Research. The studies were conducted at the University of Chicago, which has licensed patents for the use of nasal IGF-1 to treat migraines to Seurat. According to the article, the formulation demonstrated the potential of … [Read more...] about Seurat reports data from preclinical studies of intranasal IGF-1