GIMOTI Offers a Different Route to Relief—Your Nose

Of people with diabetic gastroparesis, 65% are not satisfied with their current treatment. Unlike pills that may not be absorbed, GIMOTI can work even when you're nauseated and vomiting.^1,2

Image of Gimoti® (metoclopramide) nasal spray

The GIMOTI difference:

Absorbed directly into the bloodstream from the nose³
No need to pass through the stomach to start working¹
Symptom relief is not affected by delayed stomach emptying¹

Fewer emergency visits with GIMOTI

Compared to people who took oral metoclopramide, people who took GIMOTI nasal spray had^4,5:

60%

fewer emergency
room visits

68%

fewer hospital
stays

36%

fewer visits to a
doctor’s office

When looking at healthcare visits for nausea, vomiting, and diabetic gastroparesis over a 6-month period.

This was a study that reviewed and evaluated different types of healthcare visits for 514 people with diabetic gastroparesis over a 6-month period. Of the people this study looked at, 257 took oral metoclopramide and 257 took GIMOTI. All people in this study were 18 years of age or older.^4†

^†This study was designed to look back at a group of patients who were prescribed GIMOTI or oral metoclopramide. It’s possible that the selection of these patients could have introduced a bias. To reduce this bias, patients were matched based on their disease severity and other characteristics. It’s also possible these results could be due to other factors associated with the treatment that these patients received. Any small errors in this data are likely the same across both groups of patients.⁴

Questions about GIMOTI?

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GIMOTI is approved for the relief of diabetic gastroparesis symptoms

In a clinical study, women with diabetic gastroparesis who began with moderate to severe symptoms reported relief as early as 1 week after starting GIMOTI^6,^†

Symptoms included: nausea, vomiting, stomach pain, early satiety (feeling full quickly), and bloating
Compared to those who used a nasal spray without metoclopramide, GIMOTI users found up to a⁶:

higher reduction
in NAUSEA '79% higher reduction in abdominal pain' icon

higher reduction in ABDOMINAL PAIN

What is the most important information I should know about GIMOTI?

GIMOTI can cause serious side effects, including: TARDIVE DYSKINESIA: Abnormal muscle movements, mostly of the face or tongue muscles. You cannot control these movements, and they may not go away even after stopping GIMOTI. Your chances of getting tardive dyskinesia increase

The longer you take metoclopramide and the more metoclopramide you take. You should not take GIMOTI for more than 8 weeks at a time, and you should not take products containing metoclopramide (including GIMOTI) for more than 12 weeks at a time.
If you are older, especially if you are an older woman (e.g., age 65 years and older)
If you have diabetes

^‡GIMOTI was studied in 205 women with diabetic gastroparesis and delayed gastric emptying. The results in a smaller group of women who started the study with moderate to severe symptoms were also analyzed. In this smaller group, 52 of the women used GIMOTI and 53 of the women used a placebo nasal spray.⁶

Real patients. Real stories.

Video thumbnail of a diabetic gastroparesis patient

“
I sprayed it up my nose, closed my eyes. The medication worked. It worked. No more vomiting. We were able to do something that we had not done in a while—go out to dinner, sit down, and eat.”
– Tammy, actual GIMOTI patient^§

“
GIMOTI changed my outlook on life. I can actually get up, and I can mingle. I can run and play with my grandkids.”
– Kawanis, actual GIMOTI patient^§

^§Patients featured on this page are paid spokespeople for EVOKE PHARMA^®. Individual results may vary.

Possible side effects of GIMOTI

In clinical trials, the most common side effects reported were unpleasant taste after dosing, headache, and tiredness.^3,7

Tardive dyskinesia (TD) has been observed with metoclopramide use^3,8:

During the clinical trials for GIMOTI, there were no reports of TD⁷
The data suggest that the risk of TD from using metoclopramide is likely less than 1%.^8,¶ The absolute risk of TD is still not known, and further studies are required

^¶This percentage is based on 7 studies published between 1984-2008. Individual genetics may affect how some people respond to medications like metoclopramide and other factors may make some people more at risk of developing TD.

Explore GIMOTI

References: 1. Gajendran M, Sarosiek I, McCallum R. Metoclopramide nasal spray for management of symptoms of acute and recurrent diabetic gastroparesis in adults. Expert Rev Endocrinol Metab. 2021;16(2):25-35. doi:10.1080/17446651.2021.1886922 2. Yu D, Ramsey FV, Norton WF, et al. The burdens, concerns, and quality of life of patients with gastroparesis. Dig Dis Sci. 2017;62(4):879-893. doi:10.1007/s10620-017-4456-7 3. Gimoti^® (metoclopramide) nasal spray [prescribing information]. Solana Beach, CA: EVOKE PHARMA^®. 2021. 4. Kunkel D, Quesenberry C, Shokoohi M, Kish J, Cyhaniuk A. Reducing real-world healthcare resource utilization for patients with diabetic gastroparesis (DGP) treated with metoclopramide nasal spray versus oral metoclopramide. Presented at: Digestive Disease Week; May 7-9, 2023; Chicago, IL. 5. Data on file. EVOKE PHARMA^®. 6. McCallum RW, Parkman HP, Fass R, Bhandari BR, Carlson MR, Buck RD. Metoclopramide nasal spray in women with symptomatic diabetic gastroparesis: a randomized, double-blind, placebo-controlled phase 3 study. Clin Gastroenterol Hepatol. 2023;1-9. doi:10.1016/j.cgh.2023.10.022 7. Data on file. EVOKE PHARMA^®. 8. Rao AS, Camilleri M. Review article: metoclopramide and tardive dyskinesia. Aliment Pharmacol Ther. 2010;31(1):11-19. doi:10.1111/j.1365-2036.2009.04189.x 9. Camilleri M, Kuo B, Nguyen L, Vaughn VM, et al. ACG Clinical Guideline: Gastroparesis. Am J Gastroenterol. 2022;117(8):1197-1220. doi:10.14309/ajg.0000000000001874

*Patients are not eligible for copay assistance if they are enrolled in any state or federally funded healthcare programs, such as Medicare and Medicaid, or where prohibited by law. Certain eligibility criteria apply; for Terms and Conditions, please visit gimotirx.com/terms.

IMPORTANT SAFETY INFORMATION

What is Gimoti^® (metoclopramide) nasal spray?

GIMOTI is a prescription medicine used 30 minutes before meals and at bedtime for 2 to 8 weeks to relieve symptoms of slow stomach emptying in adults with diabetes. Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks.

GIMOTI is not recommended for use in children under age 18.

Important facts about GIMOTI

This is a summary of important information you need to know about GIMOTI. This information does not take the place of talking with your healthcare professional about your medical condition or your treatment.

What is the most important information I should know about GIMOTI?

GIMOTI can cause serious side effects, including: TARDIVE DYSKINESIA: Abnormal muscle movements, mostly of the face or tongue muscles. You cannot control these movements, and they may not go away even after stopping GIMOTI. Your chances of getting tardive dyskinesia increase

The longer you take metoclopramide and the more metoclopramide you take. You should not take GIMOTI for more than 8 weeks at a time, and you should not take products containing metoclopramide (including GIMOTI) for more than 12 weeks at a time.
If you are older, especially if you are an older woman (e.g., age 65 years and older)
If you have diabetes

Call your healthcare professional right away if you get movements you cannot stop or control, such as lip smacking, chewing, or puckering up your mouth; frowning or scowling; sticking out your tongue; blinking and moving your eyes; shaking of your arms and legs.

Do not use GIMOTI if you

Have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking GIMOTI or a medicine that works like GIMOTI
Have stomach or intestinal problems that could get worse with GIMOTI, such as bleeding, blockage, or a tear in the stomach or bowel wall
Have a type of tumor that can cause high blood pressure, such as pheochromocytoma
Have epilepsy (seizures)
Are allergic to metoclopramide. Stop taking GIMOTI right away and get emergency help if you have any of these symptoms:
- swelling of your tongue, throat, lips, eyes, or face
- trouble swallowing or breathing
- skin rash, hives, sores in your mouth, or skin blisters

Before starting GIMOTI, tell your healthcare professional about all your medical conditions, especially if you have

Problems controlling your muscle movements after taking any medicine
Parkinson’s disease
Pheochromocytoma
Kidney or liver disease
Depression or mental illness
High blood pressure

Also tell your healthcare professional if you are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, or drink alcohol.

Tell your healthcare professional about all the medicines you take, including prescription drugs and over-the-counter medicines, vitamins, and herbal supplements.

Speak with your healthcare professional before you start or stop any other medicines.

Especially tell your healthcare professional if you take

Another medicine that contains metoclopramide, such as REGLAN^® tablets
Medicine for Parkinson’s disease
Blood pressure medicine
Medicine for depression, especially a monoamine oxidase inhibitor (MAOI)
Antipsychotic medicine used to treat mental illness, such as schizophrenia
Insulin
Medicines that can make you sleepy, such as anxiety medicines, sleep medicines, and narcotics

What should I avoid while taking GIMOTI?

Do not drink alcohol while taking GIMOTI
GIMOTI may cause sleepiness or dizziness. Do not drive, operate machinery, or do potentially dangerous activities until you know how GIMOTI affects you

What are other possible side effects of GIMOTI?

Other changes in muscle control and movement, such as:
- uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia)
- parkinsonism – slight shaking, body stiffness, and trouble moving or keeping your balance
- being unable to sit still or feeling that you need to move your hands, feet, or body (akathisia)
Neuroleptic Malignant Syndrome (NMS) – a very rare but very serious condition. NMS can lead to death and must be treated in a hospital
Depression, thoughts about suicide, and suicide
High blood pressure
Too much body water
Increased prolactin

Call your healthcare professional and get medical help right away if you

Feel depressed or have thoughts about hurting or killing yourself
Have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and/or increased sweating
Have muscle movements that you cannot stop or control
Have muscle movements that are new or unusual

The most common side effects of GIMOTI include

Unpleasant taste after dosing
Headache
Tiredness

These are not all the possible side effects of GIMOTI. Ask your healthcare professional for medical advice about side effects.

You may report side effects related to Evoke Pharma products by calling 1-833-4-GIMOTI (1-833-444-6684) or emailing GIMOTImedinfo@evokepharma.com. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

This information should not take the place of you talking with your doctor or healthcare professional. If you have any questions about your condition, or if you would like more information about GIMOTI, talk to your doctor or pharmacist. Only you and your healthcare professional can decide if GIMOTI is right for you.

Please see complete Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.