Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti™ NDA
The CRL, which cites fewer issues than the recent multidisciplinary review letter, states that
The clinical pharmacology issue was specific to a low Cmax in subjects representing less than 5% of the total administered Gimoti doses in the pivotal pharmacokinetic (PK) study. The Agency stated the overall lower mean Cmax was driven by the data from these few subjects. Without the aberrant doses, the Company’s analysis shows the data met the bioequivalence criteria for both men and women. The Agency recommended a root cause analysis to determine the origin of the PK variability and mitigation strategies to address the issue. Additionally,
“We believe that the issues cited in the CRL, which were related to concerns over reproducible dose delivery, can be addressed. We look forward to meeting with
Gastroparesis is a debilitating, episodic condition that disproportionately affects adult women and is characterized by slow or delayed gastric emptying of the stomach’s contents after meals, often resulting in flares of symptoms that include nausea, vomiting, abdominal pain and bloating. Vomiting and gastric emptying delays can cause unpredictable absorption of food and oral medications, which complicate glucose control and can lead to dehydration and malnutrition. These clinical manifestations of gastroparesis also potentially render existing oral drug treatment options ineffective. If approved, Gimoti would be the first non-oral drug treatment for symptoms associated with acute and recurrent diabetic gastroparesis in adult women and would represent the first significant advancement in the treatment of gastroparesis in 40 years.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat Gastrointestinal (GI) disorders and diseases. The Company is developing Gimoti, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Metoclopramide is currently available only in oral and injectable formulations and is the only drug currently approved in
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Source: Evoke Pharma, Inc.