Evoke Pharma Receives Positive NDA Submission Guidance From U.S. FDA For Gimoti
Healthy volunteer bridging study to oral metoclopramide to be completed and submitted in NDA with existing safety and efficacy data
SOLANA BEACH, Calif., Dec. 15, 2016 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced positive guidance from a recent second pre-NDA (New Drug Application) meeting to discuss clinical data for inclusion in a 505(b)(2) NDA for Gimoti™ with the US Food and Drug Administration (FDA). This pre-NDA meeting was the second for Gimoti™, Evoke's patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
Following discussion of the clinical data Evoke provided for this meeting, the FDA agreed that demonstration of equivalent exposure to the listed drug (Reglan® 10 mg Tablets) in a healthy volunteer pharmacokinetic (PK) trial could serve as a portion of an NDA for Gimoti. Upon demonstration of appropriate exposure in a PK trial, Evoke will submit the PK data and prior clinical studies to the Agency for review in the Gimoti NDA. The FDA agreed that no new efficacy or safety study would be required, if bioequivalence criteria were met. During NDA review and labeling negotiations, safety and efficacy data from completed Gimoti studies, including the thorough ECG study, may be used to support information included in the Gimoti label.
For this pre-NDA meeting, the Company provided Phase 3 data that showed statistically significant efficacy compared to placebo for patients with moderate to severe symptoms at baseline in a post-hoc analysis. The moderate to severe population consisted of more than half of the 205 women participating in the trial. The benefit for Gimoti compared to placebo in this population was demonstrated at various time points in the intent-to-treat, per protocol, and completer populations. In addition, favorable safety data from the placebo-controlled studies in diabetic gastroparesis patients and the studies in healthy volunteer will support the planned Gimoti NDA.
In the first pre-NDA meeting with the FDA held in August 2016, Evoke confirmed various regulatory, chemistry, manufacturing, and control (CMC), and non-clinical requirements for the Company's potential NDA submission. "Our meeting with the FDA represents another positive step forward for our clinical program and our path to an NDA submission," stated, Dave Gonyer, R. Ph., President and CEO. "With the FDA's guidance, Evoke intends to complete an additional pharmacokinetic trial and file an NDA, without the need for additional efficacy studies. Given these two positive pre-NDA meetings, we believe the Company is well-positioned to move forward to an NDA and potential approval of Gimoti for diabetic gastroparesis in adult women."
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.
SOLANA BEACH, Calif., Dec. 15, 2016 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced positive guidance from a recent second pre-NDA (New Drug Application) meeting to discuss clinical data for inclusion in a 505(b)(2) NDA for Gimoti™ with the US Food and Drug Administration (FDA). This pre-NDA meeting was the second for Gimoti™, Evoke's patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
Following discussion of the clinical data Evoke provided for this meeting, the FDA agreed that demonstration of equivalent exposure to the listed drug (Reglan® 10 mg Tablets) in a healthy volunteer pharmacokinetic (PK) trial could serve as a portion of an NDA for Gimoti. Upon demonstration of appropriate exposure in a PK trial, Evoke will submit the PK data and prior clinical studies to the Agency for review in the Gimoti NDA. The FDA agreed that no new efficacy or safety study would be required, if bioequivalence criteria were met. During NDA review and labeling negotiations, safety and efficacy data from completed Gimoti studies, including the thorough ECG study, may be used to support information included in the Gimoti label.
For this pre-NDA meeting, the Company provided Phase 3 data that showed statistically significant efficacy compared to placebo for patients with moderate to severe symptoms at baseline in a post-hoc analysis. The moderate to severe population consisted of more than half of the 205 women participating in the trial. The benefit for Gimoti compared to placebo in this population was demonstrated at various time points in the intent-to-treat, per protocol, and completer populations. In addition, favorable safety data from the placebo-controlled studies in diabetic gastroparesis patients and the studies in healthy volunteer will support the planned Gimoti NDA.
In the first pre-NDA meeting with the FDA held in August 2016, Evoke confirmed various regulatory, chemistry, manufacturing, and control (CMC), and non-clinical requirements for the Company's potential NDA submission. "Our meeting with the FDA represents another positive step forward for our clinical program and our path to an NDA submission," stated, Dave Gonyer, R. Ph., President and CEO. "With the FDA's guidance, Evoke intends to complete an additional pharmacokinetic trial and file an NDA, without the need for additional efficacy studies. Given these two positive pre-NDA meetings, we believe the Company is well-positioned to move forward to an NDA and potential approval of Gimoti for diabetic gastroparesis in adult women."
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.