First Patient Enrolled in Study of Novel Intranasal Formulation and Delivery of Metoclopramide
vSOLANA BEACH, CA, USA I April 22, 2014 I Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the initiation of its Phase 3 clinical trial investigating the use of EVK-001, a novel metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women.
“We are very pleased to have our Phase 3 clinical trial for EVK-001 underway with the enrollment of our first patient into the study,” said David Gonyer, R.Ph., President and Chief Executive Officer of Evoke Pharma. “Our goal is to address an important unmet need in treating gastroparesis: a therapy that can improve the GI symptoms, including nausea and vomiting, that are characteristic of this disorder. Building on our successful Phase 2 placebo-controlled study, this Phase 3 study is designed to confirm the results that showed EVK-001 is an effective and well-tolerated drug candidate for women with diabetic gastroparesis.”
“Gastroparesis in patients with diabetes can be very difficult to treat. There are limited FDA-approved options and the absorption of oral medications can be unpredictable,” said lead investigator Dr. Henry P. Parkman, Director of the GI Motility Laboratory at the Temple University School of Medicine. “EVK-001 has shown promising safety and efficacy results in previous diabetic gastroparesis studies and may provide a valuable treatment alternative for this patient population. Unlike oral medications, intranasal delivery bypasses the GI tract and directly enters the bloodstream, allowing predictable absorption regardless of the gastric emptying delays and symptom flares associated with the disease.”
Gastroparesis is a disorder in which the stomach is delayed in emptying its contents to the small intestine (in the absence of an obstruction). Characteristic symptoms are nausea, vomiting, abdominal pain, early satiety and bloating. Gastroparesis interferes with absorption of food and medications in the GI tract due to unpredictable gastric emptying and vomiting. Symptom flares vary in severity and diminish quality of life, negatively impact blood glucose control, and may lead to complications requiring hospitalization. The potential gastroparesis patient pool in the United States is approximately 12 to 16 million adults, with women making up over 80% of the affected population.
The Phase 3 clinical trial is a four-week, multicenter, placebo-controlled, double-blind, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult female subjects with diabetic gastroparesis and is expected to enroll 200 patients at sites across the United States. The trial is expected to be completed in 2015.
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 EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic 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. EVK-001 is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through intranasal administration.
SOURCE: Evoke Pharma
Post Views: 25
First Patient Enrolled in Study of Novel Intranasal Formulation and Delivery of Metoclopramide
vSOLANA BEACH, CA, USA I April 22, 2014 I Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the initiation of its Phase 3 clinical trial investigating the use of EVK-001, a novel metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women.
“We are very pleased to have our Phase 3 clinical trial for EVK-001 underway with the enrollment of our first patient into the study,” said David Gonyer, R.Ph., President and Chief Executive Officer of Evoke Pharma. “Our goal is to address an important unmet need in treating gastroparesis: a therapy that can improve the GI symptoms, including nausea and vomiting, that are characteristic of this disorder. Building on our successful Phase 2 placebo-controlled study, this Phase 3 study is designed to confirm the results that showed EVK-001 is an effective and well-tolerated drug candidate for women with diabetic gastroparesis.”
“Gastroparesis in patients with diabetes can be very difficult to treat. There are limited FDA-approved options and the absorption of oral medications can be unpredictable,” said lead investigator Dr. Henry P. Parkman, Director of the GI Motility Laboratory at the Temple University School of Medicine. “EVK-001 has shown promising safety and efficacy results in previous diabetic gastroparesis studies and may provide a valuable treatment alternative for this patient population. Unlike oral medications, intranasal delivery bypasses the GI tract and directly enters the bloodstream, allowing predictable absorption regardless of the gastric emptying delays and symptom flares associated with the disease.”
Gastroparesis is a disorder in which the stomach is delayed in emptying its contents to the small intestine (in the absence of an obstruction). Characteristic symptoms are nausea, vomiting, abdominal pain, early satiety and bloating. Gastroparesis interferes with absorption of food and medications in the GI tract due to unpredictable gastric emptying and vomiting. Symptom flares vary in severity and diminish quality of life, negatively impact blood glucose control, and may lead to complications requiring hospitalization. The potential gastroparesis patient pool in the United States is approximately 12 to 16 million adults, with women making up over 80% of the affected population.
The Phase 3 clinical trial is a four-week, multicenter, placebo-controlled, double-blind, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult female subjects with diabetic gastroparesis and is expected to enroll 200 patients at sites across the United States. The trial is expected to be completed in 2015.
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 EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic 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. EVK-001 is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through intranasal administration.
SOURCE: Evoke Pharma
Post Views: 25
