US FDA accepts Evoke's CMC and PK trial plan for nasal metoclopramide

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Food and drug administration, Fda

The US FDA has accepted a manufacturing and trial plan for Evoke Pharma's Gimoti, the nasal metoclopramide formulation that fell short in a Phase III trial last year.

Eovoke announced​ the “positive” meeting with the US regulator this week, explaining it has paved the way for the submission of Gimoti – a version on Mylan’s Reglan intended to treat the symptoms of diabetic gastroparesis in women with diabetes mellitus – by early 2018.

The firm said “agreement was received on items related to the CMC section of the NDA,” ​but did not provide details.

It added the US Food and Drug Administration (FDA) had also approved the structure, population and overall design of a pharmacokinetic (PK) trial Evoke plans to conduct in the second half of the year.

Phase III emdpoint missed

The positive meeting comes less than a year after Evoke announced​ that Gimoti –previously known as EVK-001 – failed to achieve its primary endpoint in a Phase III​, placebo-controlled study in women suffering diabetic gastroparesis.

The Ph III result – which Evoke CEO Dave Gonyer described as an “unexpected anomaly, given that metoclopramide has been approved and used for treating diabetic gastroparesis for more than 35 years​” – saw the firm’s share price nose dive when they were announced last July.

However, the finding did not prompt Evoke to abandon Gimoti. Instead the firm held its first pre-NDA meeting with the FDA the following month during which it confirmed regulatory, chemistry, manufacturing, and control (CMC), and non-clinical requirements.

During a subsequent meeting in December the FDA agreed that a healthy volunteer pharmacokinetic (PK) trial could serve as a portion of the NDA along with the Phase III results.

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