americanpharmaceuticalreviewOctober 30, 2020
Tag: Evoke , EVERSANA , Gimoti , diabetic gastroparesis
Evoke Pharma and EVERSANA™ have announced 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,” said 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,” said 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.”
“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,” Jim Lang, CEO of EVERSANA, said.
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.
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