- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Positive Results Reported for Metoclopramide Nasal Spray for Gastroparesis in Diabetics
Intranasal delivery more effective than oral tablets in mid-stage trial (January 22)
A new study has found that metoclopramide nasal spray (EVK-001, Evoke Pharmaceuticals) is more effective in managing the symptoms of diabetic gastroparesis compared with the marketed oral tablet formulation of metoclopramide.
The phase IIb trial, which was published online in Neurogastroenterology & Motility, enrolled 89 patients in the U.S. The randomized, open-label, parallel-design study was the first to compare the efficacy and safety of metoclopramide nasal spray with that of oral tablets in diabetic patients with symptoms of gastroparesis when dosed four times a day for 6 weeks.
No new drugs for the management of symptoms associated with gastroparesis have been approved by the FDA since 1980, and few agents are currently in clinical development for this debilitating diabetic complication.
Source: Evoke Pharmaceuticals; January 22, 2014.