Evoke’s experience with Thermo wins Patheon nasal metoclopramide contract

By Dan Stanton contact

- Last updated on GMT


Related tags: New drug application, Pharmacology, Food and drug administration

Evoke Pharma has selected Patheon to commercially manufacture its nasal delivery formulation of metoclopramide Gimoti ahead of a planned US FDA submission next year.

The contract development and manufacturing organisation (CDMO) has signed a five-year agreement to commercially manufacturer the Gimoti nasal spray on behalf of Evoke Pharma.

Gimoti – previously known as EVK-001 – is a nasal delivery formulation of metoclopramide intended for the relief of symptoms associated with acute and recurrent diabetic gastroparesis

The partnership with Patheon was announced as “another critical step”​ in Gimoti’s development by Evoke’s CEO Dave Gonyer, coming 16 months after the candidate failed to achieve its primary endpoint in a Phase III​​ placebo-controlled study.

But earlier this year​, Evoke reported a “positive”​ pre-submission meeting with the US Food and Drug Administration (FDA) and in this latest news Gonyer has confirmed his firm is preparing and finalising a New Drug Application (NDA) submission with the Agency within the first quarter next year.

Thermo Fisher

Patheon was acquired by life sciences firm Thermo Fisher Scientific in August​ for $7.2bn, and Gonyer said this was an influencing factor on his choice of CDMO.

“We believe that Thermo Fisher’s recent acquisition of Patheon, a CDMO who we have worked closely with since 2008, provides additional expertise in the manufacturing of nasal spray products and makes them an ideal partner.”

In May​, Evoke contracted regulatory consulting third-party Rho to prepare and submit the NDA itself.

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