SOLANA BEACH, Calif., Sept. 20, 2022 (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 announced the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S. Application No. 16/469,092 for GIMOTI. When granted, the patent will cover methods for treating moderate-to-severe gastroparesis with metoclopramide with an intranasal route of administration. Once issued, the patent, entitled “Treatment of Moderate and Severe Gastroparesis,” will expire in 2037. The patent will add to Evoke’s existing U.S. Food and Drug Administration (FDA) Orange Book-listed patents and other patents in the EU, Japan, and Mexico.
GIMOTI is the first and only FDA-approved novel nasal formulation of metoclopramide that is commercially available and specifically designed to deliver a non-oral dose of metoclopramide for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Non-oral delivery is an important treatment option as gastroparesis causes oral medications to be unpredictably absorbed and vulnerable to one of the key symptoms of the disease, vomiting.
“The patent protects our Phase 3 clinical trial outcomes and data showing efficacy with nasal metoclopramide formulations for persons suffering from moderate-to-severe diabetic gastroparesis. The grant of this new patent further enhances Evoke’s growing position in this market and our continued efforts to ensure patients and doctors have access to GIMOTI in the U.S.,” commented Matt D’Onofrio, Chief Business Officer of Evoke Pharma. “Through market surveys and healthcare provider and patient anecdotes, we’ve learned that there is an imperative need for a nasal formulation of metoclopramide rather than the traditional standard of care. Therefore, we believe the transition from oral administration of metoclopramide to a nasal route is revolutionary for both patients and doctors, and we are thrilled to have IP protections in place to protect a novel product like GIMOTI,” Mr. D’Onofrio continued.
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 anticipated scope and term of any patent protection for Gimoti and the expected inclusion of any new patent in the FDA’s Orange Book. 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 obtain, maintain and successfully enforce intellectual property protection for Gimoti; Evoke’s and EVERSANA’s ability to successfully drive market demand for Gimoti; Evoke’s ability to obtain additional financing as needed to support its operations; the COVID-19 pandemic may continue to disrupt Evoke’s and EVERSANA’s business operations impairing the ability to commercialize Gimoti and Evoke’s ability to generate any product revenue; Evoke’s dependence on third parties for the manufacture of Gimoti; Evoke is entirely dependent on the success of Gimoti; inadequate efficacy or unexpected adverse side effects relating to Gimoti that could result in recalls or product liability claims; 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.
Investor Contact:
Daniel Kontoh-Boateng
DKB Partners
Tel: 862-213-1398
dboateng@dkbpartners.net
