Neurelis has announced plans to conduct a clinical trial of Valtoco diazepam nasal spray in children with epilepsy aged 2-5 and said that the company intends to file an sNDA to expand the use of Valtoco to include this population sometime in 2021. The FDA approved Valtoco for the treatment of seizure clusters in patients 6 years old and older in January 2020 and … [Read more...] about Neurelis announces clinical trial of Valtoco in epilepsy patients aged 2-5
Medical
Alaxia partners with University of Padua to evaluate ALX-009 inhalation solution against SARS-CoV-2
French biotech company Alaxia has announced a collaboration with the Department of Molecular Medicine (DMM) at the University of Padua for in vitro testing of its ALX-009 hypothiocyanite / lactoferrin inhalation solution against SARS-CoV-2 as a possible treatment for COVID-19. The company has been developing ALX-009 as an inhaled antimicrobial for the treatment of … [Read more...] about Alaxia partners with University of Padua to evaluate ALX-009 inhalation solution against SARS-CoV-2
Ampio announces planned Phase 1 trial of inhaled Ampion in COVID-19 patients
Ampio Pharmaceuticals said that the FDA has cleared its IND for clinical trials of an inhaled formulation of its Ampion anti-inflammatory biologic in patients with COVID-19. The company had announced its plans to develop Ampion for the treatment of COVID-19 in March 2020. According to Ampio, preclinical toxicology studies demonstrated that Ampion would be safe for … [Read more...] about Ampio announces planned Phase 1 trial of inhaled Ampion in COVID-19 patients
TFF to advance its dry powder voriconazole to Phase 2 after successful Phase 1 trial
TFF Pharmaceuticals has announced that it will advance its voriconazole inhalation powder into Phase 2 development for the treatment of invasive pulmonary aspergillosis following completion of a Phase 1 trial that demonstrated plasma levels that should be sufficient for effective treatment. Topline safety results from the trial were reported in June 2020, and in July, … [Read more...] about TFF to advance its dry powder voriconazole to Phase 2 after successful Phase 1 trial
Starpharma says tests show its astodrimer sodium nasal spray formulation effectively inactivates SARS-CoV-2
Starpharma has announced that testing of its SPL7013 astodrimer sodium intranasal formulation at the Scripps Research Institute demonstrated that the formulation inactivated nearly 100% of SARS-CoV-2 with low cellular toxicity. The company already markets several astodrimer sodium products under the VivaGel brand in a number of countries, including a VivaGel condom … [Read more...] about Starpharma says tests show its astodrimer sodium nasal spray formulation effectively inactivates SARS-CoV-2
Phase 3 trial of Satsuma’s DHE nasal powder for migraine fails to meet primary endpoints
Satsuma Pharmaceuticals said that the Phase 3 EMERGE trial of its STS101 dihydroergotamine nasal powder for the treatment of migraine failed to demonstrate statistically significant improvement in either pain relief or the patient's most bothersome symptom compared to placebo for either of the doses tested at two hours post dosing. The company had announced the … [Read more...] about Phase 3 trial of Satsuma’s DHE nasal powder for migraine fails to meet primary endpoints
AZTherapies announces initiation of Phase 2a trial of inhaled cromolyn for ALS
AZTherapies has announced the initiation of a Phase 2a clinical trial of its ALZT-OP1a inhaled cromolyn in patients with mild- to moderate-stage amyotrophic lateral sclerosis (ALS). The randomized open-label trial is expected to enroll 80 ALS patients who will receive, in addition to standard of care, either 17.1 mg of cromolyn via DPI twice a day or 34.2 mg twice a … [Read more...] about AZTherapies announces initiation of Phase 2a trial of inhaled cromolyn for ALS
Marinomed submits MAA for xylometazoline decongestant nasal spray
Marinomed Biotech said that it has submitted an MAA via the decentralized marketing authorization procedure for a xylometazoline decongestant nasal spray formulated with the company's Carragelose red algae extract. The company currently markets a range of non-prescription nasal sprays based on Carragelose, including Coldamaris; the xylometazoline spray will be its … [Read more...] about Marinomed submits MAA for xylometazoline decongestant nasal spray
Destiny Pharma and SporeGen get £800,000 grant for bacillus nasal spray for prevention of COVID-19
Destiny Pharma and SporeGen have agreed to co-develop a bacillus nasal spray as a prophylactic for prevention of COVID-19, with much of the project cost covered by an £800,000 grant from Innovate UK. Pan Group subsidiary Huro will develop and manufacture the formulation, and the companies say that they expect to begin clinical trials by early 2022. Preclinical … [Read more...] about Destiny Pharma and SporeGen get £800,000 grant for bacillus nasal spray for prevention of COVID-19
Verona initiates trial of ensifentrine MDI in hospitalized COVID-19 patients
Verona Pharma has initiated a study of its ensifentrine MDI in patients hospitalized with COVID-19 at the University of Alabama Birmingham (UAB), the company said. The company has been developing the MDI formulation for the treatment of COPD and recently initiated a Phase 2b trial for that indication after a delay caused by the pandemic. Verona also has nebulized and … [Read more...] about Verona initiates trial of ensifentrine MDI in hospitalized COVID-19 patients