FDA approves Gimoti for diabetic gastroparesis
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Evoke Pharma announced in a press release that the FDA has approved the new drug application for Gimoti nasal spray to relieve symptoms in adults with acute and recurrent diabetic gastroparesis.
“We are extremely pleased to have received FDA approval to commercially market Gimoti [metoclopramide, Evoke Pharma] in the United States,” David Gonyer, R.Ph, president and CEO, said in the release. “This approval represents the first novel pharmaceutical treatment for gastroparesis in several decades. Many times, patients do not experience adequate relief of their gastroparesis symptoms from current treatments, representing a significant need for a new approach to therapy. We are excited to be able to offer healthcare providers and their patients a unique non-oral treatment option to relieve symptoms and help improve their quality of life.”
According to the release, the FDA approval will allow Evoke to access its existing $5 million line of credit from Eversana to support manufacturing and other aspects of metoclopramide commercialization. Evoke anticipates its line of credit combined with approximately $4.7 million in cash and cash equivalents will support Evoke’s operations into 2021, not including the potential metoclopramide revenue.
“Together with our partner Eversana, we are now fully focused on executing our commercialization strategy for Gimoti by leveraging Eversana’ s integrated suite of capabilities and highly experienced sales and marketing team,” Gonyer said. “We anticipate initiating commercial sales in the fourth quarter of 2020.”
Perspective
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Michael Cline, DO
The medication in Gimoti is not a new medication. Gimoti is a new formulation of the drug. It is currently the only FDA-approved drug for gastroparesis in the United States. It’s actually a drug that we don’t want to use a lot because of its potentially dangerous side effects. However, there are cases when the use of the medication can help with the treatment. For example, the drug can be given if the patient can’t keep anything down orally, and we have to do something acutely in the hospital. It is not a drug that we want to put a patient on long term because of the side effect potential. The unique part of this report is not so much the drug, but its delivery. That is, the transnasal approach that would bypass the patient needing to swallow the medication or have it put intravenously. That’s the more interesting part. It gives us another way of administrating the drug even if it’s short term. It’s beneficial for patients, especially in acute settings, because it’s much easier to use a transnasal approach than swallowing a pill. People who suffer from gastroparesis often throw up and experience nausea. Now that we have this drug available in the United States, we should investigate other drugs that could be administered transnasally. This can open doors to other research on alternative approaches to help treat gastroparesis.
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