FDA accepts IND application for OX640 epinephrine nasal powder

The FDA accepted an investigational new drug application for the epinephrine intranasal powder OX640 for treating anaphylaxis, according to a press release from Orexo.
“Although epinephrine is well established as a treatment, significant challenges remain with today’s injection-based products,” Nikolaj Sørensen, MSc, president and CEO of Orexo, said in the release.
The limitations of current epinephrine autoinjectors per the release include fear of needles, use errors, and storage and shelf-life challenges. Data included in the investigational new drug application for OX640 (extensive

SetPoint System ‘increasing its effectiveness over time’ in RA

HUNTINGTON BEACH, Calif. — Vagus nerve stimulation with the SetPoint System offers a new and promising approach for patients with refractory rheumatoid arthritis, according a speaker at the Congress of Clinical Rheumatology West.
“Vagal nerve stimulation is a new option now proven for patients with RA,” Jeffrey Curtis, MD, MS, MPH, Marguerite Jones Harbert-Gene V. Ball endowed professor of medicine at the University of Alabama at Birmingham, told Healio. “It is the first new mechanism of action that we have had in RA in the last 14 years, since JAK inhibitors. Its excellent safety