Weekly Roundup 4.4.14

Dumbfounded by another week packed with business travel.  It was a week that truly involved planes, trains and automobiles.  I wish I could say that it will be a while before I am once again in an airport, but it would not be so.  In any case, home today for the first time in a week, and here is a bit of what happened that was pretty newsworthy that came out while I was standing in one line or another.

  • Approval of Sublingual Allergen Extract – FDA announced approval on April 3 of a new tablet called Oralair manufactured by a French company called Stallergenes.  Oralair is a once-daily dose and indicated for the treatment of hay fever induced by grass pollens and is the first under the tongue (sublingual) extract approved in the United States.  The first dose is administered in the physician’s office and thereafter can be taken home for use.  Oralair contains a mixture of freeze-dried extracts of pollens of five different grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.  One interesting note for those of us in the pharma communications trade – FDA’s press release came out two days after the company announced approval with its own release dated April 1 and hence the unusual language in the FDA release that was dated April 3 which stated that the agency had “recently approved Oralair”.
  • Opioid Overdose Treatment – It is an unfortunate circumstance that drugs meant to alleviate the serious pain of people suffering from disease are not only often abused, but in a way that puts a life in danger from overdose.  In fact, drug overdose deaths are not the leading cause of injury death in the United States, according to FDA, suppressing motor vehicle crashes.  This week FDA approved a new hand-held auto injector to be used in an attempt to reverse the effects of an opioid overdose treatment that can be used by families or law enforcement for emergency treatment called Evzio.  Evzio contains a single dose of naloxone that is administered by a hand held auto-injector.  This is a step forward over what had been the status quo which involved administration by syringe from trained medical personnel.  The announcement was accompanied by a statement from Commissioner Hamburg regarding FDA efforts to combat prescription drug abuse.
  • Battlefield Wound Dressing – More successful innovation emerged this week when FDA announced it would allow marketing of an expandable sponge that could be used under emergency circumstances to control bleeding for “certain types of wounds received in battle.”  FDA’s release notes that the U.S. Army says that nearly half of all combat deaths are due to bleeding out and that approximately half of those could be saved if appropriate care – presumably something to stop the bleeding – could be available.  The sponges are administered by syringe and expand into the wound and are later removed from the body.  To support the removal process, each sponge contains a marker that is visible when X-rayed.

That’s it for me this week.  I am working today to produce a few think pieces for next week so that there are some more postings outside of the Weekly Roundup – due to the really busy schedule I have had since the New Year started.  Have a wonderful weekend everyone.

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