Medical

VistaGen Therapeutics said that the PALISADE-1 Phase 3 clinical trial of PH94B aloradine nasal spray for the treatment of anxiety in social anxiety disorder failed to meet its primary endpoint. The company announced the initiation of the PALISADE-1 trial in May 2021, and a second Phase 3 trial, PALISADE-2, got underway in September 2021. According to VistaGen, "the … [Read more...] about Phase 3 trial of VistaGen’s PH94B nasal spray for social anxiety disorder fails to meet primary endpoint

CyanVac subsidiary Blue Lake Biotechnology said that dosing has begun in a Phase 1 clinical trial of the company's BLB-201 intranasal vaccine against respiratory syncytial virus. The open label trial is expected to enroll 15 healthy adults aged 18 to 59 and 15 adults aged 60 to 75 who will each receive a single intranasal dose of BLB-201. The company had announced … [Read more...] about Phase 1 trial of Blue Lake’s BLB-201 intranasal vaccine for RSV gets underway

Impel Pharmaceuticals said that it has initiated a Phase 2a study of its INP105 intranasal olanzapine in adolescents with autism spectrum disorder, with results expected early next year. In January 2019, Impel (then Impel Neuropharma) announced positive Phase 1 results for INP105, which it was developing at the time for the treatment of acute agitation in bipolar I … [Read more...] about Impel initiates Phase 2a study of INP105 intranasal olanzapine in autistic adolescents

According to researchers from the Duke Clinical Research Institute (DCRI) and Vanderbilt University, the ACTIV-6 study of repurposed medicines for the treatment of mild-to-moderate COVID-19 has found that inhaled dry powder fluticasone furoate provided no benefit compared to inhaled placebo. Results have been published on medRxiv in an article titled "Inhaled … [Read more...] about Study finds fluticasone furoate DPI ineffective for the treatment of COVID-19

Odyssey Health said that a Phase 1 single ascending dose trial of PRV-002 nasal spray, which it describes as "a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion)," has been completed. According to Odyssey, the trial found a linear dose response, and all dose levels were safe and well tolerated. In addition to … [Read more...] about Odyssey Health says PRV-002 nasal spray safe and well tolerated in Phase 1 SAD trial

Glenmark Pharmaceuticals and SaNOtize have announced the publication of results from a Phase 3 clinical trial of NONS nitric oxide nasal spray for the treatment of COVID-19 in The Lancet Regional Health Southeast Asia. SaNOtize announced initiation of the Phase 3 trial in June 2021, and Glenmark announced in August 2021 that it had acquired the rights to NONS in India … [Read more...] about Glenmark and SaNOtize publish positive results from Phase 3 trial of nitric oxide nasal spray for COVID-19

Pulmatrix said that the first subjects have been dosed in a Phase 1 trial of the company's PUR3100 dry powder dihydroergotamine (DHE), which is based on Pulmatrix's iSPERSE particle engineering platform. The company announced in March 2021 that it intended to develop the PUR3100 DPI for the treatment of migraines. The Phase 1 trial is expected to enroll 24 healthy … [Read more...] about Pulmatrix initiates Phase 1 trial of PUR3100 inhaled dry powder DHE

US-based startup RS BioTherapeutics has announced that a proof of concept study demonstrated that its RSBT-001 semi-synthetic cannabidiolic acid (CBDa) reduced but did not eliminate cytokines when dosed intranasally at 1 mg/kg in a mouse model of pulmonary inflammation. The study was conducted by researchers at Marshall University. RS BioTherapeutics licensed the … [Read more...] about RS BioTherapeutics reports positive preclinical results for its inhaled CBDa

Danish startup Cessatech, a spin out from Rigshospitalet, announced that it has gotten the go-ahead for a pivotal trial of its CT001 analgesic nasal spray. Cessatech is developing CT001, a fixed dose combination of sufentanil and ketamine, for use in pediatric patients and has already completed dosing in a Phase 2 PK study of the nasal spray in children aged 1-17. … [Read more...] about Cessatech announces plans for pivotal trial of CT001 intranasal analgesic