Three weeks after recalling numerous lots of desmopressin nasal sprays in the UK and a number of other countries, Ferring has issued a recall of all lots of DDAVP 10 mcg/0.1ml, Stimate 1.5 mg/ml, and generic desmopressin 10 mcg/0.1ml nasal sprays in the US "due to superpotency or amounts of desmopressin higher than specified." The recall includes 6 lots of DDAVP, 15 … [Read more...] about Desmopressin nasal sprays recalled in US
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Phase 3 trial of Levo’s intranasal carbetocin for PWS misses primary endpoint
A Phase 3 trial of Levo Therapeutics' LV-101 intranasal carbetocin in children with Prader-Willi Syndrome (PWS) failed to meet its primary endpoint, the company said. Enrollment in the study, which began in 2018, was stopped earlier than anticipated due to the COVID-19 pandemic, winding up with 119 patients in the primary analysis set. The CARE-PWS trial compared … [Read more...] about Phase 3 trial of Levo’s intranasal carbetocin for PWS misses primary endpoint
NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19
The FDA has cleared an IND for NeuroRx to conduct a clinical trial of an inhaled formulation of its RLF-100 aviptadil in patients with moderate or severe COVID-19, the company said. NeuroRx recently announced that an intravenous formulation of RLF-100 has shown promising results in patients with severe COVID-19 and that researchers in Brazil have demonstrated that … [Read more...] about NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19
Atossa gets approval for Phase 1 study of AT-301 nasal spray
Atossa Therapeutics said that it has gotten the go-ahead for a Phase 1 clinical study of its AT-301 nasal spray, which the company is developing for the treatment of COVID-19, and expects to begin enrollment within a month. Atossa previously announced that it had contracted with Summit Biosciences for development and manufacturing of the nasal spray and with Advance … [Read more...] about Atossa gets approval for Phase 1 study of AT-301 nasal spray
TFF says dosing complete in Phase 1 trial of its dry powder voriconazole
TFF Pharmaceuticals said that the final subject has been dosed in a Phase 1 SAD/MAD study of its voriconazole inhalation powder, which the company is developing for the treatment of invasive pulmonary aspergillosis (IPA). The SAD/MAD study was initiated in November 2019, and the company recently announced topline safety results from the trial. TFF President and … [Read more...] about TFF says dosing complete in Phase 1 trial of its dry powder voriconazole
Milestone Pharmaceuticals raises $25 million, provides update on etripamil development
Milestone Pharmaceuticals said that it has raised $25 million from RTW Investments in a private placement and indicated that the proceeds would be sufficient for company operations through the second quarter of 2022. The company also announced that it had reached an agreement with the FDA regarding modifications to the design of a pivotal trial of its etripamil nasal … [Read more...] about Milestone Pharmaceuticals raises $25 million, provides update on etripamil development
VistaGen announces details of proposed Phase 3 trial of PH94B nasal spray for anxiety
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
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