Sunovion Pharmaceuticals’ new drug application (NDA) for its Parkinson’s disease treatment, apopmorphine sublingual film, designed to treat OFF episodes, was met with a complete response letter (CRL) by the US Food and Drug Administration (FDA).
The CRL noted that the drug could not be approved in its current form, as it needed additional data and analysis, though no new clinical studies will be required.
According to a statement from Sunovion’s chief medical officer, Antony Loebel, “OFF episodes are a common and challenging part of Parkinson’s disease with few existing treatment options.”
Sunovion licensed this drug from Aquestive Therapeutics, and while the drug is not part of the Aquestive pipeline, the company acknowledged the CRL. Aquestive stated that the therapy is still important to the Parkinson’s disease community and it is supporting the drug, despite regulatory issues.
Keith Kendall, CEO of Aquestive, stated, “[The therapy] remains indicative of the future value in our intellectual property license with Sunovion. We will continue to proactively engage in opportunities to monetize all of our passive assets.”
This is not the first CRL Aquestive has experienced in recent months – in November 2018, the company received a CRL from the FDA in response to its NDA for its generic version of Eli Lilly’s Cialis (tadalafil oral film).
Similar to the recent CRL, Aquestive was required by regulatory officials to add more data to the NDA. Additionally, the company switched the supplier for the active pharmaceutical ingredient (API) needed for the drug candidate due to ‘quality control’ issues with the previous partner.