SOLANA BEACH, Calif., March 14, 2019 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has submitted its response to the U.S. Food and Drug Administration’s (FDA) multi-disciplinary review (DR) letter that was received on March 1, 2019 in association with the Gimoti 505(b)(2) New Drug Application (NDA).
In addition, the Company requested a meeting with the FDA prior to the Prescription Drug User Fee Act (PDUFA) action date of April 1, 2019. The meeting was granted and will be held on March 21, 2019. The purpose of this meeting is to obtain FDA’s feedback on the Company’s responses.
“We look forward to meeting with FDA next week, ahead of the PDUFA target date to review the supplemental materials in our response and respond to any additional questions the Agency may have,” said Dave Gonyer, President and CEO.
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.
About Evoke Pharma, Inc.
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 the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.
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: the potential timing of FDA action on the NDA and potential approval; the timing and purpose of the meeting between Evoke and the FDA, and Evoke’s ability to address the deficiencies raised in the DR letter. 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 FDA may choose to postpone or cancel the meeting; Evoke may be unable to successfully address the concerns raised by the DR letter; the FDA may not be able to fully consider Evoke’s response before it takes final action on the NDA; the increased risk of the FDA issuing a Complete Response Letter (CRL) based on the deficiencies raised in the DR letter or other issues identified by the FDA as it completes its review of the NDA; the potential delay in the PDUFA target action date; the inherent risks of clinical development of Gimoti; Evoke could face significant additional costs due to additional regulatory requests, litigation or other events; Evoke is entirely dependent on the success of Gimoti, and Evoke cannot be certain that FDA will approve the NDA for Gimoti; Evoke will require substantial additional funding to address any deficiencies raised in a potential CRL, and may be unable to raise capital or obtain funds when needed, including to fund ongoing operations; and other risks detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Source: Evoke Pharma, Inc.
Posted: March 2019
- Evoke Pharma’s Gimoti NDA Accepted for FDA Review – August 16, 2018
- Evoke Announces FDA Submission of New Drug Application for Gimoti – June 4, 2018
- FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application – March 5, 2018
Gimoti (metoclopramide) FDA Approval History
Source: Read Full Article