FDA Approves Nasal Metoclopramide

The Food and Drug Administration (FDA) recently announced the approval of a nasal spray that relieves the symptoms of diabetic gastroparesis. The metoclopramide spray, GIMOTI, is the first new drug treatment for gastroparesis in decades. This non-oral treatment provides another option for people whose symptoms haven't been relieved with traditional oral medications. GIMOTI requires a prescription and is generally used for 2 to 8 weeks.

What is Diabetic Gastroparesis?

An estimated 50% of diabetics experience some degree of gastroparesis in their lifetime. The disorder causes delayed gastric emptying of food from the stomach into the small intestines. The symptoms can develop slowly, but eventually, they can impact your daily activities and quality of life.

Cause

Diabetic gastroparesis usually develops when a person’s blood sugar is poorly controlled over a long period of time. A complication of high blood sugar is nerve damage, which can occur anywhere in the body. The vagus nerve controls the muscles in your stomach wall and is the main culprit in diabetic gastroparesis. When the vagus nerve is damaged, the stomach walls do not contract properly and food doesn't move into the small intestines.

Symptoms

The symptoms of gastroparesis are caused by food remaining in the stomach because of slowed digestion. Common symptoms include:

• Heartburn or reflux
• Feeling full, even with small amounts of food
• Constipation alternating with diarrhea
• Feeling bloated
• Nausea
• Vomiting undigested food
• Unintended weight loss
• Lack of appetite
• Stomach cramps or spasms
• High or low blood sugars

Oral Treatments

Oral medications, such as metoclopramide, are used to treat symptoms of gastroparesis. These medications help your stomach muscle move food and liquids to your intestines faster. They may also aid in better digestion of food. However, because of slowed gastric emptying and vomiting with gastroparesis, the absorption of oral medications is not always reliable.

Better Predictability

In an Evoke Pharma press release, Dr. Henry Parker, Director at Temple University School of Medicine’s Gastroenterology Motility Laboratory, stated, “These patients often have erratic absorption of orally administered drugs due to delayed gastric emptying”. Dr. Parker further explains that the GI tract is bypassed since GIMOTI is administered nasally, stating this allows “the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy”.

Potential Side Effects

The side effects of GIMOTI are similar to oral metoclopramide. The most common side effects (<5%) include:

• Altered sense of taste
• Headache
• Fatigue

Tardive dyskinesia (TD) is a serious adverse reaction and the risk of TD increases with the length of treatment and cumulative dosage. TD is serious and is a movement disorder that can be permanent. However, the symptoms of TD may lessen or even go away once metoclopramide is stopped. Symptoms of TD include uncontrolled movements, such as

• Lip-smacking, chewing or pursed lips
• Frowned face
• Sticking tongue out
• Blinking and eye movements
• Shaking of arms and legs

Find full prescribing information including a complete list of side effects.

Limitations of Use

GIMOTI is not recommended for use in:

• Pediatrics patients due to risk of TD and extrapyramidal symptoms
• Moderate or severe hepatic impairment
• Patients using strong CYP2D6 inhibitors

GIMOTI is contraindicated in patients with the following:

• History of tardive dyskinesia
• GI motility might be dangerous (e.g. GI hemorrhage, mechanical obstruction, perforation)
• History of dystonic reaction to metoclopramide
• Pheochromocytoma or catecholamine-releasing paragangliomas
• Diagnosis of epilepsy
• Hypersensitivity to metoclopramide

Dosing

GIMOTI is available in a 9.8 ml bottle with 1 spray proving 15 mg of metoclopramide. Common adult dosing is one spray in 1 nostril before each meal and at bedtime.