Evoke Pharma Secures New U.S. Patent for GIMOTI
Evoke Pharma, Inc. (NASDAQ: EVOK), a dedicated player in the pharmaceutical landscape, has made significant strides with the announcement of a new U.S. patent for its leading product GIMOTI. This development marks a pivotal moment for the company, further solidifying its commitment to patients suffering from gastrointestinal (GI) disorders.
Details of the New Patent
The newly issued patent, numbered 12,377,064, particularly addresses the use of intranasal metoclopramide for patients who experience moderate to severe symptoms of gastroparesis. This patent, granted by the United States Patent and Trademark Office (USPTO), is a testament to the innovative approaches Evoke is taking in the treatment of GI diseases.
Extended Patent Exclusivity
One of the most significant aspects of this patent is the extension of its exclusivity period to November 2038, thanks to patent term adjustments (PTA). This extension prolongs GIMOTI’s market presence well beyond the previously expected expiration of patent protection in December 2036. Such prolongation is vital for a specialty pharmaceutical company focused on meeting the unique needs of patients.
Importance of GIMOTI for Patients
Matt D’Onofrio, the CEO of Evoke Pharma, expressed enthusiasm regarding the patent extension, emphasizing its importance as Gastroparesis Awareness Month unfolds. He indicated that this extension not only strengthens their intellectual property position but also reinforces the company's dedication to offering a non-oral treatment option for diabetic gastroparesis patients.
Addressing Gastroparesis Symptoms
The patent encompasses methods of alleviating symptoms linked to gastroparesis through the intranasal administration of metoclopramide. This promising approach caters to patients exhibiting specific symptom severity, a key aspect of Evoke’s ongoing development efforts. Additionally, the company is pursuing further claims via a continuation application to broaden the patent's scope.
Commitment to the Gastroparesis Community
Evoke Pharma is deeply committed to raising awareness about gastroparesis. During Gastroparesis Awareness Month, the company reaffirms its pledge to enhance the lives of those challenged by this debilitating condition. Their innovative treatments aim to address the significant challenges faced by millions suffering from GI disorders.
About GIMOTI
GIMOTI serves as a nasal spray solution that exerts its therapeutic effects for adults who grapple with fading GI function due to diabetic gastroparesis. This drug is particularly crucial as it offers an alternative for patients who struggle with the absorption of orally administered medications, as gastroparesis can delay gastric emptying.
Safety Considerations and Potential Risks
While GIMOTI has shown promise in the management of gastroparesis symptoms, it is essential for patients to be aware of its safety profile. The most significant risk associated with metoclopramide includes tardive dyskinesia (TD), a serious movement disorder that, if developed, can become irreversible.
Precautions and Contraindications
Patients should discontinue the use of GIMOTI if they observe any symptoms indicative of TD. Moreover, it should be noted that this treatment is not recommended for pediatric patients or those with certain hepatic or renal impairments, emphasizing the need for healthcare providers to assess individual patient risks carefully.
Looking Ahead
With this new patent in hand, Evoke Pharma is better poised to advance its mission of supporting patients with diabetic gastroparesis. This achievement highlights the company’s dedication to innovation and patient care, ensuring that those with debilitating symptoms have access to effective treatment options.
Investor and Media Inquiries
For those seeking more information about Evoke Pharma and its offerings, the company can be reached through their contact media representative, Daniel Kontoh-Boateng at DKB Partners. Interested parties can connect via telephone or email to discuss the exciting developments regarding GIMOTI and the company’s journey forward.
Frequently Asked Questions
What is GIMOTI?
GIMOTI is a nasal spray formulation of metoclopramide designed to treat acute and recurrent diabetic gastroparesis symptoms in adults.
How long is the exclusivity period for GIMOTI now?
The exclusivity period for GIMOTI has been extended to November 2038 due to recent patent adjustments.
What are the potential side effects of GIMOTI?
Potential side effects include dysgeusia, headache, fatigue, and a risk of tardive dyskinesia.
Why is the patent extension significant?
The patent extension allows Evoke Pharma to maintain market exclusivity, enabling further investment in the development and marketing of GIMOTI.
How does GIMOTI help gastroparesis patients?
GIMOTI provides a non-oral treatment alternative for diabetic gastroparesis patients, addressing issues related to delayed gastric emptying and medication absorption.
