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

04-Apr-2017 - Last updated on 05-Apr-2017 at 12:16 GMT

iStock/Koldunov

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.