Aquestive receives CRL, switches API supplier over concerning ‘quality controls’

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Ilkercelik)
(Image: Getty/Ilkercelik)

Related tags: Aquestive, Cialis, tadalafil, Fda

Aquestive’s NDA to the US FDA was knocked back over API issues, but the company still expects the product to be available by 2020.

The firm’s tadalafil oral film candidate is a generic version of Eli Lilly’s Cialis, a treatment for erectile dysfunction.

The New Jersey-headquartered firm is readying the product for market entry in 2020, but received a setback when the US Food and Drug Administration (FDA) issued a complete response letter (CRL).

According to the company, the regulator demanded additional data to form part of its new drug application (NDA). Aquestive also confirmed it would be looking to work with an alternative supplier of the active pharmaceutical ingredient (API) for the product.

A spokesperson explained to us why it had taken the decision: “We decided to engage an alternate supplier because of new concerns about the quality controls with a supplier of the tadalafil API.”

“We have identified an alternate supplier for this API, and feel their reputation for quality manufacturing aligns better with our own commitment to patient and product safety,”​ the spokesperson continued.

Both new and previous API supplier identities remain undisclosed but the spokesperson confirmed that the switch would not change its expected market entry timeline, which will follow the expiration of Lilly’s patents on tadalafil in 2020.

According to company research, there is a demand for the product as patients using the erectile dysfunction treatment “value discreteness and portability​,” and the “oral film technology may provide both of these benefits.”

Last month​, the FDA approved Aquestive’s Sympazan (clobazam), a treatment for Lennox-Gastaut syndrome, that also uses PharmaFilm technology as an oral film drug delivery option.

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