Breaking News
April 26, 2018 - Researchers create new tool to measure patient uncertainty for predicting hospital readmissions
April 26, 2018 - FDA Alert: Lamictal (lamotrigine): Drug Safety Communication
April 26, 2018 - Massive single-cell survey of kidney cell types reveals new paths to disease
April 26, 2018 - Cognitive behavioral therapy can help children with autism manage emotional challenges
April 26, 2018 - CU Anschutz Medical Campus receives NIH grant to speed up discovery of new treatments
April 26, 2018 - Researchers discover significant distortions in leading genetics study method
April 26, 2018 - New combination therapy could improve survival in children with high-risk neuroblastoma
April 26, 2018 - Scientists clarify casual role of oxidative stress in metabolically abnormal and healthy obesities
April 26, 2018 - Home-based exercise program found ineffective for patients with peripheral artery disease
April 26, 2018 - Choroidal Thickness Changes in Patients With Untreated DM
April 26, 2018 - Medical chemists discover peptic ulcer treatment metallodrug effective in ‘taming’ superbugs
April 26, 2018 - UB researchers build 3D-printed, drug-filled dentures to fight against infections
April 26, 2018 - Researchers find role of iron storage gene in slowing down prostate cancer growth
April 26, 2018 - Study suggests link between regular mid-day naps and neurocognitive function in teens
April 26, 2018 - Researchers gain ground-breaking insights into how inflammatory diseases work
April 26, 2018 - Injured U.S. Vet Receives World’s First Penis/Scrotum Transplant
April 26, 2018 - Researchers find existing drug effective at preventing onset of type 1 diabetes
April 26, 2018 - MGH researchers identify risk factors for drug overdose in youth with substance use disorders
April 26, 2018 - Researchers develop new vaccine to help people overcome bath salts abuse
April 26, 2018 - Genetic signature predicts diabetes diagnosis
April 26, 2018 - Study shows link between restless legs syndrome symptoms and brain structure
April 26, 2018 - MU researchers use new techniques to fight against diabetic retinopathy
April 26, 2018 - AAE’s new practice statements aim at improving patient care
April 26, 2018 - Expression of long non-coding RNAs can result in high levels of specific proteins involved in cancer
April 26, 2018 - FDA re-examining safety of new drug approved for Parkinson’s disease psychosis
April 26, 2018 - Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy
April 26, 2018 - Bacteria boost antifungal drug resistance in severe childhood tooth decay
April 26, 2018 - New study affirms bedtime habits of Americans
April 26, 2018 - Hospital patients are more interested in tracking their health data, research shows
April 26, 2018 - Study shows gene variations associated with malaria risk
April 26, 2018 - Inhealthcare teams up with MSKassist to combat problems related to obesity and aging
April 26, 2018 - Caffeine during pregnancy – babies 66 percent more likely to become overweight
April 26, 2018 - FDA Approves Jynarque (tolvaptan) to Slow Kidney Function Decline in Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease
April 26, 2018 - Pricey dental implants often best but insurance rarely pays
April 26, 2018 - Advion’s Peak Express software now available with the expression compact mass spectrometer
April 25, 2018 - Researchers find link between pneumonia in older people and PPI prescriptions
April 25, 2018 - Alcohol damages microbiome in the mouth
April 25, 2018 - Regular soaking in hot tub improves health outlook in obese women with PCOS
April 25, 2018 - FDA Alert: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers
April 25, 2018 - Sunshine could hold clues on the timing for a severe form of heart attack, study says
April 25, 2018 - Sartorius Stedim Biotech launches mini bioreactor vessel for ambr 250 high throughput system
April 25, 2018 - Biofeedback-assisted relaxation may help children during medical procedures
April 25, 2018 - Key signaling protein in Huntington’s disease found to have deleterious effects on heart function, shows study
April 25, 2018 - Celecoxib Lowers Opioid Use Post Head & Neck Cancer Surgery
April 25, 2018 - New ‘brain health index’ can predict how well patients will do after stroke
April 25, 2018 - Positive interventions in sepsis management raise key questions about E. coli reduction targets
April 25, 2018 - Scientists identify new DNA structure within living human cells
April 25, 2018 - E. coli’s toxin-antitoxin system inhibits bacterial growth
April 25, 2018 - Researchers uncover reason why exercise may be beneficial for the heart
April 25, 2018 - Researcher presents case study of asymptomatic patient with severe mitral regurgitation
April 25, 2018 - Use ‘Proper Form’ When Practicing Yoga
April 25, 2018 - Study reports possible novel method for stopping untreatable pediatric brain cancers
April 25, 2018 - Visually guided walking paves way for better treatment for mobility impairments
April 25, 2018 - Researchers identify novel pathway in development of AML with poor prognosis
April 25, 2018 - Cardiovascular disease may only be a matter of time for people with healthy obesity
April 25, 2018 - Girls with type 2 diabetes have high frequency of menstrual irregularities
April 25, 2018 - Study explains why intense exercise curbs appetite
April 25, 2018 - Experimental drug for rheumatoid arthritis prevents side effect of stem cell transplants
April 25, 2018 - Why are Antibiotics Overprescribed for Meningitis Treatment?
April 25, 2018 - Consuming protein supplements with meals, rather than between meals, may promote weight control
April 25, 2018 - Seeing prostate cancer in a new light
April 25, 2018 - Jacobs Medical Center recognized with Baby Friendly Designation for efforts in mother-baby bonding
April 25, 2018 - Gene related to high fatality could be used as biomarker in patients with P. aeruginosa infection
April 25, 2018 - Study shows patients in major prostate cancer study are more likely to die than real-world patients
April 25, 2018 - HBP researchers develop new tool to examine role of genes in disease-relevant brain regions
April 25, 2018 - Trio’s pioneering silicone ostomy product wins prestigious Queen’s Award for Enterprise
April 25, 2018 - Study highlights potential of stem cells derived from adults in regenerative medicine
April 25, 2018 - A new, emerging procedure burns cancer cells
April 25, 2018 - Acclarent introduces real-time, 3D navigation system for ENT procedures
April 25, 2018 - Italy’s prestigious Veneto Institute of Oncology acquires MILabs’ latest VECTor5CT system
April 25, 2018 - Future screening is more likely for people with false-positive cancer screening results
April 25, 2018 - Tweezers made of laser beams manipulate atoms to make new molecules
April 25, 2018 - Elevated immune function during childhood linked to stunted growth
April 25, 2018 - FDA Accepts New Drug Application for Duvelisib and Grants Priority Review
April 25, 2018 - Research reveals autism and schizophrenia share common traits
April 25, 2018 - Perceived stress decreases for most women over 15-year span, study finds
April 25, 2018 - Coastal Genomics’ LightBench integrated with Hamilton liquid handler systems to bring efficiencies, savings for clinical laboratories
April 25, 2018 - Researchers discover new gene associated with aortic aneurysms
April 25, 2018 - Preantral zinc deficiency may affect fertility months
April 25, 2018 - Repurposing existing antiviral drugs for multiple infections
FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application

FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application

image_pdfDownload PDFimage_print

Treatment for Gastroparesis

FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application

SOLANA BEACH, Calif., March 05, 2018 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) d­­iseases, today announced that the U.S. Food and Drug Administration (FDA) granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $2.4 million for the 505(b)(2) New Drug Application (NDA) for Evoke’s Gimoti, nasal delivery formulation of metoclopramide for the treatment of symptoms associated with gastroparesis in women. The Company remains on track to file the Gimoti NDA next quarter.

“FDA’s grant of the PDUFA fee waiver enables us to continue to focus our resources on finalizing the Gimoti NDA filing. As we review our 2018 budget, we are able to extend our cash runway into October 2018. We continue to remain conservative with our expenditures and with a projected NDA filing next quarter, we look forward to a potential U.S. product launch in 2019,” commented Dave Gonyer, President and CEO.

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 is developing Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. Gimoti is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through nasal administration. Visit www.EvokePharma.com for more information.

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: anticipated timing to submit an NDA for Gimoti and Evoke’s projected 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: the FDA may disagree that the existing safety database is sufficient to allow an NDA submission and approval; risks associated with FDA review of the final results from the comparative exposure pharmacokinetic (PK) trial, including the FDA may not agree with Evoke’s interpretation of such results; later developments with the FDA that may be inconsistent with the already completed pre-NDA meetings and most recent correspondence; the inherent risks of clinical development of Gimoti; Evoke is entirely dependent on the success of Gimoti, and Evoke cannot be certain that it will be able to submit an NDA for Gimoti or obtain regulatory approval for or successfully commercialize Gimoti; Evoke will require substantial additional funding to conduct any new safety trials required by the FDA prior to NDA submission, and may be unable to raise capital when needed, including to fund ongoing operations; and other risks 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.

Source: Evoke Pharma, Inc.

Posted: March 2018

Gimoti (metoclopramide) FDA Approval History

Tagged with:

About author

Related Articles