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