Tradipitant

Gimoti remains the sole proprietary FDA approved treatment for symptoms of diabetic gastroparesisSOLANA BEACH, Calif., Sept. 19, 2024 (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, reaffirms its commitment to improving the lives of patients suffering from diabetic gastroparesis in light of the recent decision by the U.S. Food and Drug Administration (FDA) to not approve Vanda Pharmaceuticals new drug application (NDA) for Tradipitant, an oral drug candidate for the treatment of symptoms in gastroparesis. Patients suffering from all forms of gastroparesis need additional agents to help treat this difficult disease, and we believe patients will be disappointed given the FDA’s decision. Evoke continues to serve as a trusted partner for healthcare professionals and patients alike with its proven product, Gimoti® (metoclopramide), the first and only FDA-approved nasal spray treatment for acute and recurrent diabetic gastroparesis in adults. “While challenges in the regulatory landscape affect all of us in the industry, Evoke remains focused on improving patient outcomes and expanding access to GIMOTI, the only non-oral outpatient treatment for acute and recurrent symptoms of diabetic gastroparesis, which has already demonstrated significant benefits in real-world settings,” said Matt D’Onofrio, CEO of Evoke Pharma. “We have been able to provide Gimoti to over 4,000 patients since launch and continue to seek to inform patients and physicians about the benefits of non-oral treatments for this disease.” Diabetic gastroparesis is a serious condition and remains complex to effectively treat with only one FDA approved active molecule (metoclopramide) available. Gimoti, the nasal formulation of metoclopramide, was developed by Evoke Pharma specifically as an oral treatment due to the complexities of gastroparesis. Oral treatments are prone to faulty absorption due to the delayed gastric emptying blocking delivery or symptoms causing vomiting of pills, further complicating oral drug therapy. Those suffering from diabetic gastroparesis, who often take several oral medications, know first-hand the problems ingesting and digesting pills or tablets with this disease. To confirm the impact of GIMOTI and the nasal route of administration, Evoke has provided the first ever comparative data in the gastroparesis field showing statistically significant improvement in patient outcomes between Gimoti and oral metoclopramide. This real-world data, presented at Digestive Disease Week 2023, showed that patients with diabetic gastroparesis using Gimoti experienced significant reductions in emergency room visits (-60%, p=0.007) and hospitalizations (-68%, p=0.005) compared to oral metoclopramide over a six-month period. Furthermore, 61.5% of patients in this study that were treated with Gimoti had previously taken oral metoclopramide, suggesting that some patients that did not experience relief of symptoms with oral metoclopramide gained relief with a new treatment of GIMOTI. A separate cost analysis revealed that GIMOTI reduced the total cost of care by approximately $15,000 within the first six months of initiation compared to oral metoclopramide. Evoke Pharma’s commitment to quality and innovation continues to drive its mission to provide patients with reliable and effective treatments for gastroparesis. As the field evolves, particularly with the emergence of gastroparesis linked to GLP-1 receptor agonists, Evoke is positioning to respond to these new challenges with data to support clinical decision making. “As we continue to explore the benefits of Gimoti in diabetic gastroparesis treatment, Evoke Pharma is striving to expand on our promise of providing innovative and accessible solutions for patients and healthcare providers,” said Chris Quesenberry, Chief Commercial Officer of Evoke. “While having additional therapies would be beneficial to patients and providers, it would also be supportive of Evoke’s goal to expanded diagnosis and treatment of patients, many of whom go years without a proper diagnosis or appropriate treatment. Gaining approval for a new treatment method has proven very difficult for gastroparesis. With this recent news, it brings the total to 14 treatments in last 15 years that have failed to gain regulatory clearance. We believe GIMOTI is an important new innovation for gastroparesis patients and we remain steadfastly committed to expanding our commercial reach to ensure more patients receive the clinical value and ability to return to normal daily activities,” he added. 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. Visit www.EvokePharma.com for more information. Follow Evoke Pharma on LinkedInFollow Evoke Pharma on Twitter 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: healthcare provider and patient reactions to recent industry developments; future developments in the treatment landscape for diabetic gastroparesis; and Evoke’s commercialization plans. 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 and EVERSANA may not be able to successfully drive market demand for GIMOTI; alternative treatments for gastroparesis may be developed and may be shown to be superior to GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; 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; Evoke’s ability to maintain 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. Investor & Media Contact: Daniel Kontoh-Boateng DKB Partners Tel: 862-213-1398 dboateng@dkbpartners.net

Shares in Vanda fall 9% to $4.50 in premarket trading. Vanda Pharmaceuticals has failed to persuade the FDA to approve its gastroparesis candidate on the strength of a phase 3 trial that missed its primary endpoint. The biotech came out swinging after the knock-back, accusing the agency of sending a complete response letter that generally disregarded the evidence.Vanda CEO Mihael Polymeropoulos, M.D., had voiced frustrations with the approval process in the run-up to the PDUFA date, using an earnings call in July to tell investors the FDA was yet to schedule an advisory committee meeting despite the biotech’s “repeated requests.” The agency had told Vanda that it had found deficiencies in its filing but was yet to respond to a request for clarification, Polymeropoulos said at the time.The FDA’s identification of issues that precluded talks about labeling and post-marketing requirements suggested Vanda’s filing may have been in for a bumpy ride. That suggestion was confirmed Thursday morning when the biotech revealed it had received a complete response letter. Vanda, a company with a history of challenging the FDA, isn’t taking the setback lying down.“The CRL was conclusory in nature, generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder,” the biotech said in a statement. Vanda also took aim at the alleged tardiness of the FDA, stating the agency’s action “was delayed by more than 185 days and fails to satisfy the requirements specified by the Food, Drug and Cosmetic Act.” The biotech said the act requires the regulator to provide either an approval or an opportunity for a hearing within 180 days of submission. In this case, Vanda said, “the FDA failed to do either.”The biotech plans to continue to pursue marketing authorization for the molecule, the NK-1R antagonist tradipitant and support an expanded access program that it said is serving “several dozen” people. The persistence reflects Vanda’s view that the evidence from across its phase 2, phase 3 and open-label trials supports the use of the drug in the gastric emptying disorder. Tradipitant was no better than placebo at reducing the severity of nausea across 12 weeks of treatment in Vanda’s phase 3 trial. However, the biotech identified a baseline imbalance of rescue medication use between the treatment arms and some poor compliance with the study drug as a potential cause of the flop. Excluding patients Vanda deemed to be confounders, the study hit its primary endpoint.Vanda’s inability to get the FDA to approve the drug on the strength of a failed phase 3 further extends a long-running effort to get tradipitant to market. The biotech licensed the molecule from Eli Lilly in 2012 and had paid the drugmaker $5 million in upfront fees and milestones as of the end of 2023. Lilly started a phase 2 trial in alcohol craving in 2006. The biotech tried—and failed—to establish the molecule in eczema but kept going in other indications. Vanda is planning to file for approval in the prevention of vomiting in motion sickness this year, giving it a second crack at authorization even if it fails to find a way forward in gastroparesis.Shares in Vanda fell 13% to $4.28 in premarket trading Thursday morning.