Tardive Dyskinesia

New analyses suggest REXULTI was associated with reductions in overall neuropsychiatric symptoms and in agitation symptoms REXULTI was associated with reductions in occupational disruptiveness/caregiver distress as early as four weeks Efficacy of REXULTI for agitation symptoms confirmed across dementia severity, care setting, concomitant/prior medication use, and co-occurring neuropsychiatric symptoms REXULTI was associated with improvement in agitation symptoms in patients with and without psychosis symptoms at baseline PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)-- Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck U.S., the U.S. subsidiaries of H. Lundbeck A/S, (Lundbeck) presented new post hoc pooled analyses of two pivotal Phase 3 trials evaluating the safety and efficacy of REXULTI® (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer’s disease.1 The posters were presented on March 16 at the American Association for Geriatric Psychiatry (AAGP) 2024 Annual Meeting in Atlanta. This press release features multimedia. View the full release here: REXULTI is the first treatment approved by the U.S. Food and Drug Administration (FDA) for agitation associated with dementia due to Alzheimer’s disease.2 Agitation associated with dementia due to Alzheimer’s disease is a common neuropsychiatric condition reported in approximately half of all patients with dementia due to Alzheimer’s disease and one of the most complex and stressful aspects of caring for people living with dementia due to Alzheimer’s disease.3 Agitation symptoms include behaviors such as pacing, gesturing, profanity, shouting, shoving, and hitting.4 Otsuka and Lundbeck presented three practice-relevant posters containing post hoc analyses on the efficacy of REXULTI in patients with agitation associated with dementia due to Alzheimer’s disease, and caregiver impact at the meeting. One poster utilized the Neuropsychiatric Inventory (NPI) to explore the relationship of REXULTI on neuropsychiatric symptoms relating to agitation and occupational disruptiveness/caregiver distress related to patients’ behavior. The NPI, which is administered through a structured caregiver interview, is comprised of 12 domains of neuropsychiatric symptoms including agitation/aggression, irritability/lability, and disinhibition. Each domain is scored from best to worst based on frequency, severity, and occupational disruptiveness/caregiver distress. The analysis demonstrated that REXULTI was associated with reductions in overall neuropsychiatric symptoms and in agitation symptoms (as captured by the NPI) compared with placebo over 12 weeks. In addition, REXULTI was associated with a greater reduction in occupational disruptiveness/caregiver distress total score compared to placebo, with separation observed as early as Week 4.1 Another poster explored the efficacy of REXULTI on symptoms of agitation across different patient characteristic subgroups that are common in clinical practice, including baseline dementia severity, care setting, concomitant/prior medication use, and baseline co-occurring NPI symptoms (excluding agitation). A responder analysis based on a meaningful within-patient change threshold of ≥20-point reduction from baseline to Week 12 in the CMAI Total score was also conducted. The post-hoc analysis demonstrated that REXULTI was associated with greater improvement in symptoms of agitation than placebo across all subgroups as measured by the change from baseline in Cohen-Mansfield Agitation Inventory (CMAI) total score at Week 12.5 The final poster looked at the efficacy and safety of REXULTI in patients grouped by baseline psychosis status (with psychosis and without psychosis), with approximately a quarter of patients presenting with psychosis symptoms at baseline. The analysis showed fixed-dose REXULTI 2 or 3 mg/day was associated with greater improvements in agitation symptoms compared with placebo in both subgroups, as measured by the change in CMAI total score at Week 12. In addition, the safety and tolerability of REXULTI 0.5-3mg/day was similar between the subgroups.6 “It’s well known that the effects of dementia due to Alzheimer’s disease extend beyond the patient to caregivers whose lives are often disrupted in order to meet the significant demands of care,” said George T. Grossberg, MD, Department of Psychiatry and Behavioral Neuroscience at Saint Louis University School of Medicine. “These new analyses are important because they are the first to explore the potential impact of addressing agitation symptoms with brexpiprazole on caregiver-reported distress.” “These data reinforce the urgency to treat agitation separately from dementia due to Alzheimer’s disease and gives prescribers further confidence to choose an FDA-approved therapy to help address these symptoms,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. “We greatly appreciate the efforts of the caregivers and their families that participated in these important clinical trials.” “Family caregivers typically spend more than 20 hours a week caring for a loved one with Alzheimer’s disease,”7 said Johan Luthman, executive vice president, Lundbeck Research & Development. “The breadth of data presented at AAGP represents our continued commitment to understanding the full potential of REXULTI on agitation associated with dementia due to Alzheimer’s disease.” About Agitation Associated with Dementia Due to Alzheimer’s Disease Agitation associated with dementia due to Alzheimer’s disease is a common neuropsychiatric symptom that is reported in approximately half of all patients with dementia due to Alzheimer’s disease.3 The condition has a large impact on the quality of life for the patients, family members, and caregivers.3,8 Agitation associated with dementia due to Alzheimer’s disease covers a large group of behaviors occurring in patients with dementia due to Alzheimer’s disease, such as pacing, gesturing, profanity, shouting, shoving, and hitting.8 Symptoms of agitation are also a consistent predictor of nursing home admission in patients with dementia, including those with Alzheimer’s disease.9-11 About Brexpiprazole Brexpiprazole was approved in the U.S. in 2015 as an adjunctive therapy to antidepressants in adults with major depressive disorder (MDD) and as a treatment for schizophrenia in adults. Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment of MDD in 2017 and 2019, respectively. It was approved by the Ministry of Health, Labour and Welfare in Japan and by the European Medicines Agency (EMA) in 2018 for the treatment of schizophrenia. Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown, however the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. INDICATIONS and IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole) INDICATIONS: REXULTI is a prescription medicine used: along with antidepressant medicines to treat major depressive disorder (MDD) in adults to treat schizophrenia in adults and children ages 13 years and older to treat agitation that may happen with dementia due to Alzheimer’s disease REXULTI should not be used as an “as needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease. It is not known if REXULTI is safe and effective in children with MDD. It is not known if REXULTI is safe and effective in children under 13 years of age with schizophrenia. IMPORTANT SAFETY INFORMATION: Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of people with dementia-related psychosis without agitation that may happen with dementia due to Alzheimer’s disease. Increased risk of suicidal thoughts and actions. REXULTI and antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. Report any change in these symptoms immediately to the doctor. Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI. REXULTI may cause serious side effects, including: Cerebrovascular problems, including stroke, in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS) is a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS: high fever; changes in your pulse, blood pressure, heart rate, and breathing; stiff muscles; confusion; increased sweating Uncontrolled body movements (tardive dyskinesia). REXULTI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking REXULTI. Tardive dyskinesia may also start after you stop taking REXULTI. Problems with your metabolism such as: high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start REXULTI and then regularly during long term treatment with REXULTI. Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with REXULTI: feel very thirsty feel very hungry feel sick to your stomach need to urinate more than usual feel weak or tired feel confused, or your breath smells fruity increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start REXULTI, and then periodically during treatment with REXULTI. weight gain. You and your healthcare provider should check your weight before you start and often during treatment with REXULTI. Unusual and uncontrollable (compulsive) urges. Some people taking REXULTI have had strong unusual urges, to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having new or unusual strong urges or behaviors, talk to your healthcare provider. Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with REXULTI. Decreased blood pressure (orthostatic hypotension) and fainting. You may feel dizzy, lightheaded or pass out (faint) when you rise too quickly from a sitting or lying position. Falls. REXULTI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries. Seizures (convulsions). Problems controlling your body temperature so that you feel too warm. Do not become too hot or dehydrated during treatment with REXULTI. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water. Difficulty swallowing that can cause food or liquid to get into your lungs. Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects you. REXULTI may make you feel drowsy. Before taking REXULTI, tell your healthcare provider about all of your medical conditions, including if you: have or have had heart problems or a stroke have or have had low or high blood pressure have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start REXULTI and during treatment with REXULTI. have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol have or have had seizures (convulsions) have or have had kidney or liver problems have or have had a low white blood cell count are pregnant or plan to become pregnant. REXULTI may harm your unborn baby. Taking REXULTI during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take REXULTI during pregnancy. Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with REXULTI. There is a pregnancy exposure registry for women who are exposed to REXULTI during pregnancy. If you become pregnant during treatment with REXULTI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit . are breastfeeding or plan to breastfeed. It is not known if REXULTI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with REXULTI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REXULTI and other medicines may affect each other causing possible serious side effects. REXULTI may affect the way other medicines work, and other medicines may affect how REXULTI works. Your healthcare provider can tell you if it is safe to take REXULTI with your other medicines. Do not start or stop any medicines during treatment with REXULTI without first talking to your healthcare provider. The most common side effects of REXULTI include weight gain, sleepiness, dizziness, common cold symptoms, and restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of REXULTI. For more information, ask your healthcare provider or pharmacist. You are encouraged to report side effects of REXULTI (brexpiprazole). Please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 ( ). Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE for REXULTI. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,000 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at About Lundbeck Lundbeck US refers to the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC), a global pharmaceutical company specialized in brain diseases, including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. We have approximately 5,400 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. In the United States, H. Lundbeck A/S subsidiaries, including Lundbeck LLC and Lundbeck Pharmaceuticals LLC, employ more than 1,000 people focused solely on accelerating therapies for brain disorders. With a special commitment to the lives of patients, families and caregivers, Lundbeck US actively engages in a broad range of initiatives each year that support patient communities. For additional information, we encourage you to visit us at lundbeck.com/us and connect with us on LinkedIn and Twitter at @LundbeckUS. References Brubaker M, Wang D, Chumki S, et al. Efficacy of Brexpiprazole Across Agitation Behaviors in Alzheimer’s Disease, Including Impact on Caregivers, Analyzed Using the Neuropsychiatric Inventory: a Post Hoc Pooled Analysis of Randomized, Fixed-dose, Placebo-controlled Trials. American Association for Geriatric Psychiatry (AAGP), Atlanta, Ge., March-15-18, 2024. FDA News Release. FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease. Published: May 11, 2023. Last accessed: Feb 20, 2024. Available at: Halpern R, Seare J, Tong J, Hartry A, Olaoye A, Aigbogun MS. Using electronic health records to estimate the prevalence of agitation in Alzheimer disease/dementia. Int J Geriatr Psychiatry. 2019;34(3):420-431. Cummings J, Mintzer J, Brodaty H, et al. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition. Int Psychogeriatr. 2015;27(1):7-17. Brubaker M, Wang D, Chumki S, et al. Efficacy of Brexpiprazole in Patients With Agitation Associated With Dementia Due to Alzheimer’s Disease Analyzed by Patient Characteristics: a Post Hoc Pooled Analysis of Randomized, Fixed-dose, Placebo-controlled Trials. American Association for Geriatric Psychiatry (AAGP), Atlanta, Ge., March-15-18, 2024. Behl S, Chang D, Chen D, et. al. Efficacy of Brexpiprazole in Patients with Agitation Associated With Alzheimer’s Dementia Analyzed by Presence or Absence of Psychosis: a Pooled Analysis. American Association for Geriatric Psychiatry (AAGP), Atlanta, Ge., March-15-18, 2024. Alzheimer’s Association. 2015 Alzheimer’s Disease Facts and Figures. Alzheimer’s & Dementia 2015;11(3)332. Last accessed: 07 Mar, 2024. Available at: Fillit H, Aigbogun MS, Gagnon-Sanschagrin P, et al. Impact of agitation in long-term care residents with dementia in the United States. Int J Geriatr Psychiatry. 2021;36(12):1959-1969. Gaugler JE, Yu F, Krichbaum K, Wyman JF. Predictors of nursing home admission for persons with dementia [published correction appears in Med Care. 2009 May;47(5):606]. Med Care. 2009;47(2):191-198. Kales HC, Chen P, Blow FC, Welsh DE, Mellow AM. Rates of clinical depression diagnosis, functional impairment, and nursing home placement in coexisting dementia and depression. Am J Geriatr Psychiatry. 2005;13(6):441-449. Yaffe K, Fox P, Newcomer R, et al. Patient and caregiver characteristics and nursing home placement in patients with dementia. JAMA. 2002;287(16):2090-2097.

Fiscal year 2023 net product sales from prescriptions totaled approximately $5.2M, a 107% increase from 2022 Company projects $14M in net revenue for 2024 SOLANA BEACH, Calif., March 14, 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, today announced its financial results for the fourth quarter and full year ended December 31, 2023, and recent corporate developments. "In 2023, we focused on operational excellence to expand GIMOTI’s market share and ensure its availability for patients requiring an improved gastroparesis treatment. Our commercial team’s dedicated efforts yielded a 107% increase in year-over-year revenue,” stated Dave Gonyer, R.Ph., CEO of Evoke Pharma. “The new Healthcare Resource Utilization (HCRU) data has only been available to our commercial team since near the end of the year. We believe it is just starting to drive growth beginning with the addition of new prescribers, a rise in prescription fills, and an uptick in patient enrollments, solidifying 2023 as an important year for our product’s market presence. As of December 31, 2023, we’ve seen a 66% rise in cumulative prescribers from the previous year, totaling 1,689. Prescription fills and patient enrollments also climbed significantly by 100% and 88% respectively, year-over-year,” Mr. Gonyer added. Fourth Quarter and Full Year 2023 Developments and Recent Highlights: Continued Advocacy for GIMOTI as the Standard of Care for Diabetic Gastroparesis Treatment Healthcare resource utilization data presented at DDW 2023 revealed that there is statistically signficantly less burden on healthcare resources and facilities such as hospitical admissions, emergency department and physician office visits with patients who are being prescirbed GIMOTI versus those on oral metoclopramide.Based on the reduced utilization data, additional compelling cost data presented in a distinguished plenary session at ACG 2023 demonstrated financial savings benefits of GIMOTI for patients and payors compared to oral metoclopramide.Abstract focused on the HCRU of diabetic gastroparesis care in women using nasal metoclopramide to be presented at DDW 2024. Transitioned Pharmacy Service Partnership to ASPN Pharmacies Aiming to enhance patient prescription process and enhance revenues through ASPN’s extensive network of partners with broader PBM agreements. Fortified Patent Estate for GIMOTI Two patents issued in 2023 covering the methods of use for GIMOTI including two Orange Book listings.Teva Pharmaceuticals determination not to pursue a paragraph 4 certification against Gimoti without financial or other consideration further enhanced Evoke’s intellectual property position and eliminated 180-day exclusivity opportunity for later possible generic seeking entities for the future. Improved Cash Position In February 2024, the Company closed a $7.5M public offering with fundamental, healthcare-oriented institutional investors providing the company runway into the fourth quarter of 2024 with up to an additional $22.5M available if common stock warrants are exercised in full. Mr. Gonyer concluded, “2023 was a milestone year for GIMOTI with new real-world evidence demonstrating its superiority over traditional treatments and data showing a marked decrease in hospitalization and ER visits for GIMOTI over oral metoclopramide which translated into savings of over $15,000 per patient in only six months. Our results at major gastroenterology conferences including Digestive Disease Week 2023 have strengthened market trust in GIMOTI, bolstering our goal to make it the standard treatment for diabetic gastroparesis. Current and new IP protections, coupled with new inquiries about the prevalence GLP-1 associated diabetic gastroparesis, and the recent capital boost from our public offering further position us to scale our operations and achieve sustained business growth.” Fourth Quarter and Full Year 2023 Financial Review and Outlook For the fourth quarter of 2023, net product sales were approximately $1.7 million compared with $0.8 million during the fourth quarter of 2022, and the net loss was approximately $2.0 million, or $0.59 per share compared with $1.8 million, or $0.54 per share, for the fourth quarter of 2022. For the year ended December 31, 2023, net product sales were approximately $5.2 million compared with approximately $2.5 million for the year ended December 31, 2022, and the net loss was approximately $7.8 million, or $2.33 per share, compared with a net loss of $8.2 million, or $2.62 per share, for the year ended December 31, 2022. The year-over-year increase in revenue was due to higher net product sales in 2023, resulting from: Prescription sales through pharmacy service partnership with ASPN Pharmacy;Recapture of prescriptions sent to retail pharmacies without ability to order product; andMarketing of head-to-head real-world data comparing Gimoti to oral metoclopramide showing improvements in fewer hospitalizations and ER visits with GIMOTI. Research and development expenses totaled approximately $23,000 for the fourth quarter of 2023 compared with $27,000 for the fourth quarter of 2022. For the full year of 2023, research and development expenses were approximately $0.2 million compared with approximately $0.3 million for the prior year. For the fourth quarter of 2023 selling, general and administrative (SG&A) expenses were approximately $3.5 million compared with $2.3 million for the fourth quarter of 2022. For the year ended December 31, 2023, selling, general and administrative expenses were approximately $12.2 million versus approximately $9.6 million for the year ended December 31, 2022. The increase in SG&A costs year-over-year resulted primarily from higher marketing and Eversana profit sharing costs. We expect that selling, general and administrative expenses will increase in the future as we continue to progress with the commercialization of GIMOTI. Total operating expenses for the fourth quarter of 2023 were approximately $3.6 million compared with $2.3 million for the same period of 2022. For the year ended December 31, 2023, total operating expenses were approximately $12.6 million compared with approximately $10.3 million for the full year of 2022. As of December 31, 2023, cash and cash equivalents were approximately $4.7 million. We believe, based on our current operating plan, that our existing cash and cash equivalents, including the proceeds of approximately $6.1 million from the public offering closed in February 2024, as well as future cash flows from net product sales of Gimoti, will be sufficient to fund our operations into the fourth quarter of 2024. Evoke projects net revenue in 2024 of approximately $14 million. Evoke’s 2024 guidance is dependent on its current business and expectations, including recent growth rates in net sales, assumptions regarding reimbursements and prescription fills, as well as factors that are outside of our control, such as the global macroeconomic and geopolitical environment, continued supply chain constraints and inflationary pressures. 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 GIMOTI on FacebookFollow Evoke Pharma on FacebookFollow Evoke Pharma on LinkedInFollow Evoke Pharma on Twitter About Gimoti® (metoclopramide) nasal spray GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety InformationWARNING: 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: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, including the potential that GIMOTI could become the standard of care for gastroparesis; the potential for additional funds from the exercise of outstanding warrants and Evoke’s expected cash runway. 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 may not be able to achieve it’s guidance for 2024 including as a result of decreased demand 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; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; 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 PartnersTel: 862-213-1398dboateng@dkbpartners.net Financial Statements to Follow Evoke Pharma, Inc.Balance Sheet Evoke Pharma, Inc.Statement of Operations The Financial Statements accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/1505239a-5694-4a7e-99c2-8d96e50a84a3 https://www.globenewswire.com/NewsRoom/AttachmentNg/b26e2618-665c-4966-acc6-c45d683cb7e0

SOLANA BEACH, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc., (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti® (metoclopramide) nasal spray, today announced that the Company is scheduled to release its fourth quarter and full year 2023 on Thursday, March 14, 2024, after the market closes. Management will host a conference call and webcast with accompanying slides on Thursday, March 14, 2024, at 4:30 p.m. ET to discuss the results. The dial-in numbers for the conference call are (800) 267-6316 and (203) 518-9783 for international callers. The conference ID number is EVOKQ423. The webcast details can be found in the events section of Evoke’s investor relations page. In addition, a telephonic replay of the call will be available until March 21, 2024. The replay dial-in numbers are (888) 562-3381 for domestic callers and (402) 220-1189 for international callers. 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 for more information. Follow GIMOTI on Facebook Follow Evoke Pharma on Facebook Follow Evoke Pharma on LinkedIn Follow Evoke Pharma on Twitter 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 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: potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, including its plans to increase awareness of and access to GIMOTI; and Evoke’s future capital requirements. 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 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 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; 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