Medical

Janssen Pharmaceutical has announced that data from a Phase 3 study demonstrated significantly significant and clinically meaningful reduction of symptoms in adult patients with treatment-resistant depression who received esketamine nasal spray plus an oral antidepressant compared to those who received placebo plus an oral antidepressant. A second study in patients … [Read more...] about Positive results for Phase 3 study of intranasal esketamine for treatment-resistant depression

Engage Therapeutics has announced the initiation of the double-blind, randomized Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of inhaled alprazolam in epilepsy patients who have seizures with a predictable pattern. The company said that topline data should be available in the second half of 2019. The primary endpoint for the inpatient … [Read more...] about Phase 2b study of Staccato alprazolam for epilepsy gets underway

Leading diabetes research funder JDRF has awarded a 2-year $525,000 grant to International Diabetes Center (IDC) to support a study of intranasal insulin in Type 1 diabetes patients with hypoglycemia unawareness, the first time that JDRF has funded intranasal insulin research. JDRF has previously funded a study of Afrezza inhaled insulin used with an artificial … [Read more...] about JDRF awards grant for intranasal insulin study

A US biotech company called AOBiome Therapeutics said that it has initiated a Phase 2 study of an ammonia oxidizing bacteria (AOB) nasal spray for the prevention of episodic migraine. According to AOBiome, the nasal spray, which contains a single strain of Nitrosomonas eutropha, is expected to repopulate the nasal microbiome where it will convert naturally occurring … [Read more...] about AOBiome initiates Phase 2 trial of intranasal ammonia oxidizing bacteria for episodic migraine

Insys Therapeutics has announced that it plans to advance clinical research of a breath activated dronabinol (THC) inhaler in the second half of 2018. The company said that it plans to develop the inhaler for the treatment of anorexia in AIDS and cancer patients and for agitation in Alzheimer's disease patients. In 2015, Insys announced that it had licensed the … [Read more...] about Insys to begin clinical research program for dronabinol inhaler

Pulmotect has closed on a $12 million Series B round to fund continued clinical development of its PUL-042 inhaled immune stimulant, the company said. Pulmotect has now received more than $25 million in funding for development of PUL-042, including awards of $7.1 million from Cancer Prevention & Research Institute of Texas (CPRIT) and $3 million from The National … [Read more...] about Pulmotect raises $12 million for development of its PUL-042 inhaled immune stimulant

Boehringer Ingelheim has published results from the 52-week DYNAGITO study in The Lancet Respiratory Medicine showing that the Stiolto Respimat tiotropium bromide/olodaterol soft mist inhaler produced a 7% greater reduction in moderate-to-severe COPD exacerbations than the Spiriva Respimat tiotropium bromide SMI. According to BI, that reduction was "not reaching the … [Read more...] about Boehringer Ingelheim publishes results of study comparing Stiolto Respimat and Spiriva Respimat for COPD

Verona Pharma has announced that a Phase 2b study of its RPL554 inhaled PDE3/PDE4 inhibitor met its primary endpoint, demonstrating significant improvement in FEV1 compared to placebo at 4 weeks in patients with moderate-to-severe COPD for all 4 doses tested. The study also met secondary endpoints, with significant improvements in 12-hour average FEV1, respiratory … [Read more...] about Verona reports positive Phase 2b results for RPL554

According to an article published March 15, 2018 in the Journal of Psychopharmacology, a pilot trial of intranasal ketamine for the treatment of severe depression conducted by researchers from the University of New South Wales (UNSW) and the Black Dog Institute was suspended due to poor tolerability. The trial was halted after the first 5 patients dosed … [Read more...] about Intranasal ketamine trial halted due to side effects

Savara, which just announced the discontinuation of its Aironite development program after the failure of a Phase 2 trial to meet its endpoint, says that it has initiated a Phase 2a clinical study of Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infection. … [Read more...] about Savara initiates Phase 2 study of Molgradex for NTM lung infections