Possible circumvention for anti-nausea drug, metoclopramide, shows promise….
Gastroparesis, is a partial paralysis of the stomach in which food can remain in the stomach longer than usual. This can result in chronic nausea, vomiting, abdominal pain, and a feeling of fullness despite eating a few bites of food. Diabetes mellitus is the most common cause of gastroparesis due to damage to the vagus nerve (which controls stomach contractions to allow food into the small intestine) from years of high blood glucose.
The drug metoclopramide is one of the only drugs that can relieve the symptoms of gastroparesis. However, this medication is often taken orally, which is not ideal when dealing with stomach disease in which the drug can get stuck in the stomach and not get absorbed into the bloodstream. Bypassing the stomach and going directly into the bloodstream could circumvent this problem.
A randomized, open-label, parallel design study was performed to compare the nasal spray dosage form to oral tablets. A total of 89 participants were enrolled in the study. They were given either a 10 mg or 20 mg nasal spray or a 10 mg tablet to use 4 times a day for 6 weeks. The efficacy was evaluated using a total symptom score (TSS). The results of the study showed that the TSS for the nasal dosage groups was lower compared to the oral group, and that there was a significant difference in TSS between baseline and week 6 in nasal and oral group. Also, more side effects, especially nausea, occurred with the oral metoclopramide tablets.
In conclusion, the results from this phase IIb study show that the nasal spray form of metoclopramide is more favorable over oral dosage form. A phase III trial is already being prepared which should have more substantial data by 2015. This shows great potential, as there are approximately 10-16 million diabetic patients with signs and symptoms of gastroparesis and very few medications on the market that can effectively manage gastroparesis symptoms.
Parkman, H. et al. "Metoclopramide Nasal Spray is Effective in Symptoms of Gastroparesis in Diabetics Compared to Conventional Oral Tablet" Neuogastroenterology & Motility 25 December 2013