Exposure study determines effective dose for diabetic gastroparesis treatment

Recent study results suggest that nasal delivery of metoclopramide is effective for managing symptoms associated with acute and recurrent diabetic gastroparesis, according to a press release from Evoke Pharma.

Metoclopramide (Gimoti, Evoke Pharma) is a non-oral treatment indicated for symptoms of gastroparesis. Metoclopramide has been approved as a tablet and injection in the U.S. since the 1980s; however, non-oral applications are optimal as gastroparesis results in erratic absorption of oral medications, according to the release.

The study was an open label, 4-way crossover trial of 108 health volunteers who received a Reglan (Ani Pharms) tablet and three different doses of Gimoti delivered nasally in a randomized sequence. Two of the doses of Gimoti met the endpoint of a 90% CI for the ratio of area under the plasma concentration curve falling with the bioequivalence range of 80% to 125% of Reglan, according to the release.

Area under the plasma concentration curve and maximum observed plasma concentration increased in a dose-dependent manner. There were no clinically significant adverse events at any dose.

Based on the results, Evoke Pharma plans to submit a New Drug Application to the FDA in early 2018.

“We are very pleased this study has met our objective of demonstrating bioequivalence on the measure of [area under the plasma concentration curve] to identify a Gimoti dose,” Dave Gonyer, CEO of Evoke Pharma, said in the release. “We believe Gimoti has the potential to become the new standard of care for patients suffering from this debilitating disease, and we look forward to providing further updates regarding the NDA as we move quickly toward submission.”