Medical

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

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

AstraZeneca said that complete results from the Phase 3 ETHOS trial of its Breztri Aerosphere (PT010) budesonide/glycopyrronium/formoterol fumarate MDI demonstrated that the triple combination reduced moderate or severe COPD exacerbations by 24% compared to glycopyrronium/formoterol fumarate and by 13% compared to budesonide/formoterol fumarate. Patients using … [Read more...] about Breztri Aerosphere triple combination MDI outperforms dual combination therapies in Phase 3 trial

Gilead Sciences Chairman and CEO Daniel O'Day has announced that the company has received FDA approval for a Phase 1 trial of inhaled remdesivir and will initiate the study within a week. Trials of the inhaled antiviral formulation in COVID-19 patients are expected to begin in August 2020. O'Day said, "Remdesivir, our investigational antiviral medicine, is … [Read more...] about Gilead announces Phase 1 trial of inhaled remdesivir

Vaccine developer Intravacc has published data from a preclinical study of an intranasal whooping cough vaccine demonstrating strong immune responses in mice. The intranasal vaccine also prevented colonization of the lung, trachea, and nose by B. pertussis, the bacteria that causes whooping cough, while mice vaccinated by subcutaneous injection did experience nasal … [Read more...] about Preclinical study demonstrates potential of IntraVacc intranasal pertussis vaccine

Impel NeuroPharma has announced that the Phase 3 STOP 301 study of INP104 intranasal dihydroergotamine mesylate (DHE) for the treatment of acute migraine met its primary objectives, with 66.3% of patients experiencing pain relief and 38% experiencing freedom from pain two hours post dose. Pain relief began as early as 15 minutes post dose for 16.3% of patients using … [Read more...] about Positive Phase 3 results for Impel’s INP104 intranasal DHE for the treatment of migraine

Novartis has announced results from the Phase 3b ARGON study of Enerzair Breezhaler (QVM149) indacaterol/glycopyrronium/mometasone for the treatment of uncontrolled asthma, with the data published in the journal Respiratory Medicine. The 24-week study met its primary endpoint, demonstrating non-inferiority of high and medium doses of once-daily Enerzair Breezhaler to … [Read more...] about Phase 3 trial of Enerzair Breezhaler for uncontrolled asthma meets primary endpoint

Dutch vaccine maker Intravacc has announced that it is partnering with Wageningen Bioveterinary Research (WBVR) and Utrecht University on development of an intranasal Newcastle disease virus (NDV) vector vaccine for the prevention of COVID-19 in humans. The company said that its Vero cell platform, which is FDA approved, would serve as the basis for a scalable … [Read more...] about Intravacc, Wageningen Bioveterinary Research, and Utrecht University partner on intranasal COVID-19 vaccine