Evoke Pharma announced it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a U.S. patent application covering the use of GIMOTI (metoclopramide) nasal spray in patients with moderate to severe symptoms of gastroparesis. The patent extends market exclusivity for the drug by an additional 6 years, with expected expiration in December 2036.
The allowed application represents a continuation of U.S. Patent No. 11,517,545 and further expands Evoke's intellectual property estate around intranasal metoclopramide. Upon issuance, the company intends to list the patent in the FDA's Orange Book, extending market exclusivity for GIMOTI beyond other existing patents.
Market Response and Strategic Value
The patent announcement drove significant investor interest, with Evoke Pharma's stock gaining over 163% in Wednesday morning trading. Shares jumped from $2.66 to $7.02, trading on a volume of 65.2 million shares compared to the average volume of 15,000 shares.
"This new patent allowance adds meaningful value to the GIMOTI franchise by reinforcing protection around how and in whom the therapy is used," said Matt D'Onofrio, CEO of Evoke Pharma. The company has filed another U.S. continuation application to pursue additional claims directed to treatments for this patient population.
GIMOTI's Clinical Significance
GIMOTI represents the only FDA-approved, non-oral, self-administered formulation of metoclopramide and is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. The non-oral delivery mechanism addresses a critical therapeutic challenge, as gastroparesis causes oral medications to be unpredictably absorbed and patients are vulnerable to vomiting, a key symptom of the disease.
Diabetic gastroparesis affects millions of patients worldwide and is characterized by delayed gastric emptying, resulting in serious gastrointestinal symptoms and systemic complications. The gastric delay compromises absorption of orally administered medications, making GIMOTI's nasal spray formulation particularly valuable for this patient population.
Safety Profile and Regulatory Considerations
GIMOTI carries a boxed warning for 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. The drug is not recommended for use longer than 12 weeks due to the increased risk of developing TD with longer-term use.
The medication is contraindicated in patients with a history of tardive dyskinesia, when gastrointestinal motility stimulation might be dangerous, in patients with pheochromocytoma, epilepsy, or hypersensitivity to metoclopramide. Common adverse reactions include dysgeusia, headache, and fatigue.
Company Focus and Market Position
Evoke Pharma positions itself as a specialty pharmaceutical company focused primarily on treatments for gastrointestinal diseases. The company developed, commercialized, and markets GIMOTI as its primary therapeutic asset. Prior to FDA approval of GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis.
D'Onofrio emphasized that "backed by extensive market research, GIMOTI continues to stand out as an effective non-oral treatment for a disease that can compromise the effectiveness of pills due to slowed gastric absorption of oral medications."
