Aquestive Therapeutics Provides Update on Licensee, Sunovion Pharmaceuticals Inc.'s Apomorphine Sublingual Film (APL-130277) New Drug Application
WARREN, N.J., Jan. 31, 2019 /PRNewswire/ -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeutic problems, learned today its licensee, Sunovion Pharmaceuticals Inc., received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for apomorphine sublingual film (APL-130277). APL-130277 is a medicine to treat OFF episodes (the re-emergence or worsening of Parkinson's symptoms otherwise controlled by medications) experienced by people living with Parkinson's disease (PD).
"Additional treatment options for PD patients experiencing OFF episodes are important to the PD community. We believe interest in apomorphine film is high," said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics."While APL-130277 is not an Aquestive pipeline program, it remains indicative of the future value in our intellectual property (IP) license with Sunovion. We will continue to proactively engage in opportunities to monetize all of our passive assets."
About Aquestive Therapeutics
Aquestive Therapeutics is a specialty pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. Aquestive is advancing a late-stage proprietary product pipeline to treat CNS conditions and provide alternatives to invasively-administered standard of care therapies. The company also collaborates with pharmaceutical partners to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and proven capabilities for drug development and commercialization.
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