Announced that it has effectively completed an End-of-Phase 2 ending up in the FDA for ARX-01 today.
Commenting on the meeting, Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer mentioned, ‘We are happy to have FDA insight on the NDA requirements because of this novel approach to post-operative pain management. Given this guidance, our way to market is clear now. We believe that ARX-01 will make a meaningful effect on affected person lives by addressing the current shortcomings of IV PCA by reducing invasiveness, reducing unintended dosing errors, increasing patient flexibility and simplifying the demands on health care providers.’..Children who were Advertisement36-positive weighed nearly 50 pounds more, normally, than kids who were AD36-negative. Within the band of obese children, those with evidence of AD36 infection weighed an average of 35 pounds more than obese children who were AD36-negative. ‘This amount of extra weight is a major concern at any age group, but is indeed for a kid especially,’ said Schwimmer, who’s also director of Fat and Wellness at Rady Children’s Hospital in San Diego. ‘Obesity can be a marker for health problems like cardiovascular disease, liver disease and diabetes. An extra 35 to 50 pounds is plenty of to greatly increase those risks.’ Related StoriesAustralian experts define key features of metabolically healthy obeseResearchers discover rise in state-level obesity-related healthcare costsObesity groups take aim at states that deny insurance of weight problems treatment under affordable care actSchwimmer said he hopes this research will help shift some of the burden that falls so greatly upon obese people, specifically children.