Evoke Announces Discovery of Sex-Based Pharmacokinetic Differences for Gimoti™
In the most recent comparative exposure PK trial, measurements for women independently met bioequivalence criteria for AUC0-inf and AUC0-t at the tested Gimoti dose to be proposed in the NDA. The Company plans to submit its NDA for a female-only indication based on a dose in women with equivalent exposure to Reglan Tablets (the reference listed drug) and will submit supporting efficacy and safety data from its Phase 2b and Phase 3 trials, specifically for women, at doses similar or lower than the dose to be proposed in the NDA.
In parallel, the Company recently held an additional pre-NDA meeting with
“The discovery of a sex-based PK exposure differential for metoclopramide and Gimoti is exciting, as we believe the exposure differences may explain the efficacy results seen in our previous clinical trials where Gimoti reduced symptoms of gastroparesis in women, but not men,” commented
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: Evoke’s plans to pursue approval of Gimoti in adult women with diabetic gastroparesis; Evoke’s belief that the sex-based PK differences are important to gastroparesis treatment; Evoke’s plans with respect to the content of the NDA submission, including a proposed post-marketing risk management strategy and safety trial; and the timing of the NDA submission. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke's business, including, without limitation: the
Source: Evoke Pharma, Inc.