VistaGen Therapeutics said that the FDA has agreed to details of a proposed Phase 3 trial of the company's PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track designation for that indication in December 2019. According to VistaGen, the Phase 3 trial will include "a single-event, laboratory-simulated public … [Read more...] about VistaGen announces details of proposed Phase 3 trial of PH94B nasal spray for anxiety
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Synairgen’s inhaled interferon-beta-1a demonstrates significant benefit in hospitalized COVID-19 patients
Synairgen has announced that a Phase 2 clinical trial of its SNG001 nebulized interferon-beta-1a demonstrated that hospitalized COVID-19 patients receiving the drug were two times more likely to recover over the course of treatment; had significantly less dyspnea; and had a 79% lower risk of requiring ventilation and/or dying than patients receiving a a placebo. … [Read more...] about Synairgen’s inhaled interferon-beta-1a demonstrates significant benefit in hospitalized COVID-19 patients
Atossa to advance AT-301 nasal spray into clinical development for COVID-19
Atossa Therapeutics said that preclinical testing of its AT-301 nasal spray in VERO cells has demonstrated that it can limit SARS-CoV-2 infectivity, and the company has contracted with Australian CRO Advance Clinical for a Phase 1 trial, which is expected to begin this quarter. The company also said that it has filed provisional patent applications in the US to cover … [Read more...] about Atossa to advance AT-301 nasal spray into clinical development for COVID-19
Ferring issues recall of desmopressin nasal sprays
According to the UK's Medicines & Healthcare products Regulatory Agency (MHRA), Ferring Pharmaceuticals has recalled multiple batches of Desmospray 0.1 mg/ml desmopressin, Aspire branded desmopressin 0.1 mg/ml, and Octim desmopressin 1.5 mg/ml nasal sprays "due to a lower volume of solution being observed in the bottles, and out of specification results for the … [Read more...] about Ferring issues recall of desmopressin nasal sprays
Preclinical studies of Altimmune’s AdCOVID intranasal vaccine candidate demonstrate strong immune response in mice
Altimmune has announced that a study of its AdCOVID intranasal vaccine candidate induced a strong immune response in a mouse model. The results support advancing AdCOVID into a Phase 1 development, the company said, and it plans to begin manufacturing the vaccine for a trial in the fourth quarter of this year. The company recently said that it has partnered with … [Read more...] about Preclinical studies of Altimmune’s AdCOVID intranasal vaccine candidate demonstrate strong immune response in mice
CEBINA says azelastine nasal spray has potential for COVID-19
Vienna-based biotech incubator CEBINA (Central European Biotech Incubator and Accelerator) said that in vitro testing has shown that azelastine has anti-SARS-CoV-2 activity, and the company is discussing possible development and production of an azelastine nasal spray for the treatment of COVID-19 with Sigmapharm. CEBINA added that it has also filed a patent … [Read more...] about CEBINA says azelastine nasal spray has potential for COVID-19
PureIMS initiates Phase 1 trial of amikacin DPI for tuberculosis
Dutch inhaled drug developer PureIMS said that it has initiated a Phase 1 clinical trial of its Amikacin Cyclops DPI, which it is developing for the treatment of drug susceptible tuberculosis. The single ascending dose study is expected to enroll eight tuberculosis patients, with results anticipated later this year. The dry powder amikacin formulation is … [Read more...] about PureIMS initiates Phase 1 trial of amikacin DPI for tuberculosis
Positive Phase 1 results for Orexo’s nasal nalmefene
Orexo has announced that a Phase 1 bioavailability study of three formulations of its OX125 intranasal nalmefene compared to intramuscular nalmefene injection showed that all three were well tolerated and well absorbed. Orexo is developing both the nasal formulation of nalmefene and a nasal formulation of naloxone for the treatment of opioid overdose. Orexo VP … [Read more...] about Positive Phase 1 results for Orexo’s nasal nalmefene
Meissa Vaccines provides update on intranasal vaccines for COVID-19, RSV
Meissa Vaccines has provided updates on two intranasal live attenuated vaccines (LAVs) based on its "codon deoptimized RSV vaccine platform with the goal of creating safe, potent, stable, and cost-effective intranasal vaccines." The company said that it held a pre-IND meeting with the FDA regarding its MV-014-210 for prevention of SARS-CoV-2 and that it intends to … [Read more...] about Meissa Vaccines provides update on intranasal vaccines for COVID-19, RSV
TFF reports positive safety data from Phase 1 trial of inhaled voriconazole, initiation of inhaled tacrolimus study
TFF Pharmaceuticals has announced topline safety results from a Phase 1 trial of its inhaled dry powder voriconazole, which is in development for the treatment of invasive pulmonary aspergillosis. The study demonstrated that doses as high as 80 mg were well tolerated with no occurrence of side effects such as kidney damage or vision changes that limit doses of oral … [Read more...] about TFF reports positive safety data from Phase 1 trial of inhaled voriconazole, initiation of inhaled tacrolimus study