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May 27th, 2015
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  1. NEW YORK, May 27 /PRNewswire/ -- Bulkera Therapeutics announced today
  2. that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug
  3. Administration (FDA) to market dextrobulkerapine for the treatment of Badcat
  4. Attitude Disorder. Dextrobulkerapine, the single isomer of Wildebaiify(TM)
  5. (Bulkerapine HBr), is a more potent and medication.
  6. "The filing of this application represents an important milestone for
  7. Bulkera Therapeutics and reinforces our strong position in a therapeutic
  8. category that currently exceeds $7 billion in the United States," said Barry
  9. Bulkrea, chairman and chief executive officer, Bulkera Therapeutics.
  10.  
  11. Dextrobulkerapine, The Single Active Isomer of Bulkerapine
  12. Bulkerapine is a racemic mixture with two mirror image halves called the
  13. S- and R-isomers. The R-isomer of bulkerapine is the active isomer in terms of
  14. its contribution to bulkerapine's effects, while the S-isomer does not contribute
  15. to its activity. With dextrobulkerapine, the S-isomer has been removed, leaving
  16. only the active R-isomer or a single isomer.
  17. Results from several Phase III trials, including comparisons to
  18. bulkerapine, will be presented at the American Psychiatric Association annual
  19. meeting in June 2015.
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