Evoke Pharma Announces Issuance of New U.S. Patent for GIMOTI With Extended Exclusivity to Late 2038

SOLANA BEACH, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI^® (metoclopramide) nasal spray, today announced the official issuance of a new U.S. patent related to its product GIMOTI^®. The patent, U.S. Patent No. 12,377,064, covers the use of intranasal metoclopramide in patients with moderate to severe symptoms of gastroparesis, and has now been issued by the United States Patent and Trademark Office (USPTO).

Importantly, the patent term has been extended by the USPTO to November 2038, due to patent term adjustments (PTA), extending market exclusivity for GIMOTI^® two years beyond the previously projected expiration in December 2036. The Company plans to list this newly issued patent in the FDA's Orange Book, further strengthening GIMOTI's intellectual property position.

"We're very pleased with the issuance of this important patent and the extension of exclusivity to November 2038, especially as we observe Gastroparesis Awareness Month," said Matt D'Onofrio, CEO of Evoke Pharma. "This outcome meaningfully strengthens our intellectual property position around GIMOTI and reflects the rigor of our development efforts. With this longer protection period in place, we're better positioned to support the product's role in addressing the unique needs of patients with diabetic gastroparesis who require an effective non-oral treatment option."

The patent's claims cover methods of treating symptoms associated with gastroparesis by intranasal administration of metoclopramide specifically in patients with defined symptom severity. The Company is continuing to pursue additional related claims via a continuation application.

As part of its ongoing support of the gastroparesis community, Evoke recognizes Gastroparesis Awareness Month this August and reaffirms its dedication to improving the lives of patients facing this often-debilitating condition.

About Evoke Pharma, Inc.

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.

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 GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis.

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About Gimoti^® (metoclopramide) nasal spray

GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information:

WARNING: TARDIVE DYSKINESIA

• Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.
• Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.
• Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.
  
  

GIMOTI is not recommended for use in:

• Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.
• Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions.

GIMOTI is contraindicated:

• In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
• When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).
• In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
• In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.
• In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.
  
  

Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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 timing of updated listing in the Orange Book and the Company's plans to pursue additional intellectual property protections via a continuation application or otherwise. 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: Evoke's ability to maintain or expand intellectual property protection for GIMOTI; and other risks and uncertainties 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.

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