Aquestive Therapeutics has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in regards to its New Drug Application (NDA) for tadalafil oral film (OF). Tadalafil is a PDE5 inhibitor currently marketed in tablet form for the treatment of erectile dysfunction and benign prostatic hyperplasia (BPH) under the brand name Cialis, and for treatment of pulmonary arterial hypertension under the brand name Adcirca.
In the letter, the FDA requested limited additional data from healthy volunteers. The company has also notified the agency about its plans to engage an alternative supplier of the active pharmaceutical ingredient (API).
“The matters cited in the CRL are unique to the oral film formulation of tadalafil, and do not affect any other products that Aquestive develops, markets or manufactures. The comments provided in the CRL are manageable and we will work with the FDA to map out our path to resubmission and approval,” said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. “We continue to see a pathway to tentative approval before the expiry of the patents for the reference product. We anticipate partnering tadalafil OF once approved and the CRL has not changed our timing or intent.”
About Aquestive Therapeutics
Aquestive Therapeutics is a specialty pharmaceutical company committed to identifying, developing and commercializing differentiated products to address unmet medical needs. Aquestive Therapeutics has a late-stage proprietary product pipeline focused on the treatment of CNS diseases, and is working to advance orally-administered complex molecules that it believes can be alternatives to invasively-administered standard of care therapies. As the leader in developing and delivering drugs via its PharmFilm® technology, Aquestive Therapeutics also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms.