Insys Therapeutics said that a dose finding study of its epinephrine nasal spray that enrolled 49 healthy volunteers demonstrated that one of two doses of the nasal spray tested had a PK profile comparable to the PK profiles of EpiPen (0.3 mg) and Adrenalin (0.5 mg). In June 2018, the company reported results from a proof of concept PK study that showed similar … [Read more...] about Insys announces results from PK study of its epinephrine nasal spray
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Liquidia announces interim results from Phase 3 INSPIRE trial of inhaled treprostinil
Liquidia Technologies has announced interim data from the Phase 3 INSPIRE trial of its LIQ861 DPI treprostinil for the treatment of pulmonary arterial hypertension demonstrating that LIQ861 was well-tolerated at doses of up to about 125 μg in PAH patients after two weeks, a safety endpoint requested by the FDA. The company announced initiation of the study in January … [Read more...] about Liquidia announces interim results from Phase 3 INSPIRE trial of inhaled treprostinil
Positive Phase 1 results for Orexo’s intranasal naloxone
Orexo has announced results from a PK study of its OX124 naloxone nasal spray in 20 healthy volunteers that compared 4 development formulations of OX124 to Narcan naloxone nasal spray. According to the company, all 4 formulations of OX124 demonstrated "substantially higher" plasma concentrations of naloxone compared to Narcan, with equal or faster onset times. The … [Read more...] about Positive Phase 1 results for Orexo’s intranasal naloxone
Impel Neuropharma announces results of Phase 1 trial of INP105 intranasal olanzapine
Impel NeuroPharma has announced results from a Phase 1 PK trial of INP105 intranasal olanzapine demonstrating that the intranasal formulation achieved Tmax two times faster than Zyprexa intramuscular olanzapine and ten times faster than Zyprexa Zydis orally disintegrating tablets, with similar Cmax and AUC to the intramuscular formulation and higher plasma levels … [Read more...] about Impel Neuropharma announces results of Phase 1 trial of INP105 intranasal olanzapine
Stem Cell Medicine licenses intranasal MSC-exo technology for the treatment of autism
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
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