Biotech company Stem Cell Medicine (SCM) has announced that it licensed intranasal MSC-exo technology for the treatment of autism spectrum disorder (ASD) from Ramot, the Tel Aviv University Business Engagement Center. Preclinical studies have shown that intranasally delivered MSC-exo demonstrated significant improvement in autistic behaviors in a mouse … [Read more...] about Stem Cell Medicine licenses intranasal MSC-exo technology for the treatment of autism
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NPXe initiates Phase 3 trial of inhaled xenon for post cardiac arrest syndrome
NPXe has announced the enrollment of the first patient in a Phase 3 study of Xenex inhaled xenon gas for the treatment of post cardiac arrest syndrome (PCAS). The FDA granted Fast Track designation to Xenex for this indication earlier this year. The trial is expected to enroll 1,436 cardiac arrest patients and will compare treatment with Xenex over 24 hours in … [Read more...] about NPXe initiates Phase 3 trial of inhaled xenon for post cardiac arrest syndrome
Aradigm provides update on Apulmiq (formerly Linhaliq) dual release inhaled ciprofloxacin
Aradigm Corporation says that it has scheduled a meeting with the FDA to discuss results from the Phase 3 ORBIT-3 and ORBIT-4 trials of Apulmiq (formerly Linhaliq) dual release inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients now that a third party evaluation of the results has been completed. … [Read more...] about Aradigm provides update on Apulmiq (formerly Linhaliq) dual release inhaled ciprofloxacin
ARS Pharmaceuticals raises $20 million for clinical development of epinephrine nasal spray
According to US-based ARS Pharmaceuticals, the company has raised $20 million in Series C financing for clinical development of its ARS-1 epinephrine nasal spray for the treatment of anaphylaxis. The financing round was led by Deerfield Management. ARS said that it has submitted an IND for the intranasal epinephrine, which incorporates Aegis Therapeutics' Intravail … [Read more...] about ARS Pharmaceuticals raises $20 million for clinical development of epinephrine nasal spray
Verona initiates Phase 2 trial of RPL554 DPI for COPD
Verona Pharma said that it has initiated a Phase 2 clinical trial of its RPL554 PDE3/PDE4 inhibitor DPI. The study is expected to enroll 36 patients with moderate to severe COPD and will evaluate PK, efficacy, and safety. Verona is developing RPL554 as nebulized, DPI, and MDI formulations for various indications, including COPD, asthma, and cystic fibrosis. … [Read more...] about Verona initiates Phase 2 trial of RPL554 DPI for COPD
Insys says it plans NDA submissions for two nasal sprays in 2019
Insys Therapeutics says that it plans NDA submissions for both its naloxone and epinephrine nasal sprays in 2019. The company also noted the potential of regulatory submission for its inhaled dronabinol in the next few years. According to Insys, a PK study of the naloxone nasal spray "showed a distinctive profile for the . . . nasal spray product candidate in … [Read more...] about Insys says it plans NDA submissions for two nasal sprays in 2019
Levo Therapeutics initiates Phase 3 study of intranasal carbetocin for Prader-Willi Syndrome
According to Levo Therapeutics, the Phase 3 CARE-PWS (CARbetocin Efficacy and Safety Study in PWS) trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) has begun to enroll patients. Levo acquired the rights to the intranasal carbetocin from Ferring Pharmaceuticals in 2017 and announced in June 2018 that it planned to restart the … [Read more...] about Levo Therapeutics initiates Phase 3 study of intranasal carbetocin for Prader-Willi Syndrome
Acerus announces results from Phase 1 study of intranasal cannabis oil formulation
Acerus Pharmaceuticals said that a Phase 1 trial of its intranasal formulation of tetrahydrocannabinol-rich cannabis oil in 12 healthy volunteers demonstrated that the bioavailability of TCH from the nasal formulation was 2.2 times better than previously reported bioavailability data for oral dronabinol. Average Tmax was found to be 7 hours after administration. … [Read more...] about Acerus announces results from Phase 1 study of intranasal cannabis oil formulation
Tiziana initiates Phase 1 trial of intranasal foralumab
Tiziana Life Sciences has announced that the FDA approved the company's IND for intranasal foralumab human anti-CD3 antibody, and a Phase 1 clinical trial has begun. Tiziana licensed foralumab from Novimmune in 2014 and is developing the nasal formulation for the treatment of neurodegenerative diseases such as multiple sclerosis. The dose escalating trial, … [Read more...] about Tiziana initiates Phase 1 trial of intranasal foralumab
Phase 1 study of Novus Therapeutics’ OP0201 intranasal surfactant gets underway
Novus Therapeutics said that it has initiated a Phase 1 clinical trial of OP0201, an intranasal surfactant that the company is developing for the treatment of otitis media. The 2-week study will evaluate daily administration of 30 mg and 60 mg doses of OP0201, delivered intranasally via MDI, in 30 healthy adults. Earlier this year, the company announced that it had … [Read more...] about Phase 1 study of Novus Therapeutics’ OP0201 intranasal surfactant gets underway