Aquestive Therapeutics has learned its licensee, Sunovion Pharmaceuticals, 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."