According to Senzer, a PK study conducted by Insys Therapeutics found that a 0.35 mg dose of dronabinol delivered by Senzer's Voke inhaler achieved a similar maximum concentration as a 5.0 mg dose of Marinol oral dronabinol, with the inhaled dose reaching Cmax in 2 minutes compared to almost 2 hours for the oral dose. Insys acquired US rights to the Voke inhaler … [Read more...] about Senzer reports data from PK study of inhaled dronabinol
Medical
Phase 3 trial of intranasal esketamine fails to meet primary endpoint
Just weeks after Janssen announced that it had submitted an NDA for its intranasal esketamine for the treatment of depression, the company has presented data from a Phase 3 trial of the nasal spray that failed to meet its primary endpoint. Positive results from a previous Phase 3 study were published in May 2018. The new data from a study that enrolled 346 adults … [Read more...] about Phase 3 trial of intranasal esketamine fails to meet primary endpoint
Impel initiates Phase 1 trial of INP105 intranasal olanzapine
Impel NeuroPharma said that the first subject has been dosed in a Phase 1 study of INP105 intranasal dry powder olanzapine, which the company is developing for the treatment of acute agitation in bipolar I disorder and schizophrenia. The "SNAP 101" PK/PD trial will compare 3 doses of INP105 to 5 mg and 10 mg doses of intramuscular Zyprexa and to 10 mg of orally … [Read more...] about Impel initiates Phase 1 trial of INP105 intranasal olanzapine
Disappointing results for Phase 3b study of Bevespi Aerosphere
AstraZeneca has announced that the Phase 3b AERISTO trial of Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for moderate to very severe COPD failed to meet 2 out of 3 of its primary endpoints, including non-inferiority to umeclidinium/vilanterol on trough FEV1 and superiority on peak FEV1. Bevespi Aerosphere did demonstrate non-inferiority on peak … [Read more...] about Disappointing results for Phase 3b study of Bevespi Aerosphere
Impel initiates Phase 3 study of intranasal DHE for migraine
Impel NeuroPharma said that the Phase 3 STOP-301 safety and tolerability study of INP104 intranasal dihydroergotamine (DHE) for the treatment of migraine has gotten underway, with the first patient dosed. The company announced plans for the study in June 2018. According to Impel, recruitment for the study, which will gather data at 24 weeks and 52 weeks of … [Read more...] about Impel initiates Phase 3 study of intranasal DHE for migraine
Vectura announces results from two studies of VR647 in pediatric asthma patients
Vectura has announced results from a pharmacokinetic study of its VR647 nebulized budesonide inhalation suspension in asthma patients aged 4 to 8 and a methodology study of the use of a mouthpiece with the VR647 nebulizer (the Akita Jet nebulizer) by children aged 1 to 4. In January 2017, Vectura announced that it had received FDA approval of its IND for pediatric … [Read more...] about Vectura announces results from two studies of VR647 in pediatric asthma patients
Recall of oxymetazoline nasal spray due to P. aeruginosa contamination
Florida-based Product Quest Manufacturing has recalled a lot of CVS Health 12 Hour Sinus Relief Nasal Mist oxymetazoline nasal spray due to contamination with Pseudomonas aeruginosa. The company said that it had not received reports of any adverse events but acknowledged that use of a nasal spray contaminated with P. aeruginosa could potentially lead to deadly … [Read more...] about Recall of oxymetazoline nasal spray due to P. aeruginosa contamination
Milestone Pharmaceuticals initiates Phase 3 study of Etripamil for PSVT
Milestone Pharmaceuticals said that it has initiated a Phase 3 clinical study of etripamil, an intranasal calcium channel antagonist for the treatment of paroxysmal supraventricular tachycardia (PSVT). Results from a Phase 2 study of etripamil were announced in May 2017, and in August of that year, the company said that it had raised $55 million for Phase 3 … [Read more...] about Milestone Pharmaceuticals initiates Phase 3 study of Etripamil for PSVT
Eurocine Vaccines reports positive safety and tolerability results from study of Immunose Flu
Eurocine Vaccines said that results from a study of its Immunose Flu intranasal flu vaccine in adults aged 50-70 showed no serious adverse events and only minimal experiences of discomfort. The study, which took place during the 2017/18 flu season, enrolled 298 subjects at 5 locations in Sweden. The subjects, who had a mean age of 63, were divided into treatment … [Read more...] about Eurocine Vaccines reports positive safety and tolerability results from study of Immunose Flu
New partnership formed for development of inhaled gene therapy for cystic fibrosis
Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium (GTC), Imperial Innovations, and Oxford BioMedica have formed a partnership for development of an inhaled therapy designed to introduce a healthy copy of the CFTR gene into lung cells. Boehringer Ingelheim will finance the development and has acquired the option to license exclusive global … [Read more...] about New partnership formed for development of inhaled gene therapy for cystic fibrosis