Evoke and EVERSANA Announce Commercial Launch of Gimoti™

Product launch provides healthcare providers a novel treatment approach for patients suffering from symptoms of acute and recurrent diabetic gastroparesis

SOLANA BEACH, Calif. and CHICAGO, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, and EVERSANA™, a leading provider of global commercial services to the life science industry, are pleased to announce the commercial launch of Gimoti™ (metoclopramide) nasal spray for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

GIMOTI is specifically designed to address the unique needs of adult patients with diabetic gastroparesis by delivering an established treatment as a nasal spray that bypasses the GI tract. Adults suffering from diabetic gastroparesis may have unpredictable stomach emptying and may vomit their medications. For these reasons, oral administration may be problematic since drug absorption in the small intestine requires gastric emptying. GIMOTI, which was approved by the U.S. Food and Drug Administration in June 2020, is the first and only treatment for diabetic gastroparesis that enters the bloodstream through the nasal mucosa.

“Patients with diabetic gastroparesis often have erratic absorption of orally administered drugs due to delayed gastric emptying or are unable to keep from vomiting pills traditionally used to treat symptoms of this disease. Unlike oral medications, GIMOTI is administered nasally, bypassing the need for absorption in the GI system, allowing the drug to enter the bloodstream directly and avoiding the problem of unpredictable stomach emptying,” stated Henry Parkman, M.D., Stanley H. Lorber Research Endowment Fund and Chair, and Director, Gastroenterology Motility Laboratory, School of Medicine at Temple University. “For these patients suffering from debilitating symptoms such as nausea, abdominal pain, bloating, early satiety, and vomiting, GIMOTI is an important alternative to the current standard of care to help those that suffer from this disease.”

“The commercial launch of our novel treatment for the underserved market of patients suffering from diabetic gastroparesis is an important milestone reflecting years of clinical and product development,” commented David Gonyer, R.Ph., President and CEO of Evoke. “GIMOTI fills a major treatment gap by providing the current standard of care treatment through a non-oral delivery. With the support of an integrated commercial team from EVERSANA, we are confident in our ability to address the large and growing market opportunity. We are excited to provide patients and their prescribing physicians with a new important treatment option.”

Jim Lang, CEO of EVERSANA, added, “Evoke’s innovative approach is a welcome advancement that has the ability to change the continuum of care for treatment of adults suffering from the symptoms of diabetic gastroparesis. Powered by a full commercialization engine, a trained sales team will be immediately deployed to offer this novel approach to their targeted physician base. Patients will then get the full benefit of our access, distribution and adherence services, optimized by real-time analytics and actions. We look forward to commencing commercial availability of GIMOTI and supporting seamless physician adoption and patient access.”

IMPORTANT SAFETY INFORMATION

What is Gimoti^TM (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), antipsychot