The CRL is not totally unexpected, given that last month the company received a multi-disciplinary review (DR) letter from the FDA regarding its New Drug Application.
Shares of California-based Evoke Pharma have plunged more than 40 percent in premarket trading after the company announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the company’s gastroparesis treatment, Gimotti.
The CRL is not totally unexpected, given that last month the company received a multi-disciplinary review (DR) letter from the FDA regarding its New Drug Application. The DR letter is a type of communication issued by the regulatory agency to address early thinking on deficiencies found in an initial review of an NDA. Evoke and the FDA met near the end of March to address some of the issues and concerns raised in the DR letter.
Evoke said the CRL “cites fewer issues than the recent multidisciplinary review letter” but, in its present form, the FDA cannot approve the NDA in its current form. Despite that meeting between Evoke and the FDA near the end of March, the FDA said there are two approvability issues that will have to be addressed in an NDA resubmission. The CRL does provide direction for the potential approval of Cimotti, Evoke said. The path forward for Gimotti does not include any new clinical data. The CRL did not raise issue regarding any safety concerns, Evoke said.
The clinical pharmacology issue was specific to a low Cmax in subjects representing less than 5 percent of the total administered Gimotti doses in the pivotal pharmacokinetic study, Evoke said. In its CRL, the FDA said the overall lower mean Cmax was “driven by the data from these few subjects.” Without the aberrant doses, Evoke’s analysis shows the data met the bioequivalence criteria for both men and women, the company said. The FDA, Evoke said, recommended a root cause analysis to determine the origin of the PK variability and mitigation strategies to address the issue. Additionally, the FDA requested data from previously planned registration batches of commercial product to be manufactured by the company. These data were requested to provide additional support for the proposed acceptance criteria for droplet size distribution after actuation of the sprayer device, Evoke said in its announcement.
“We believe that the issues cited in the CRL, which were related to concerns over reproducible dose delivery, can be addressed. We look forward to meeting with FDA to gain a full understanding of the agency’s requirements for approval and remain committed to bringing our novel nasal formulation of metoclopramide to patients,” Dave Gonyer, president and chief executive officer of Evoke Pharma said in a statement.
Gimotti is designed to treat gastroparesis, a debilitating, episodic condition characterized by slow or delayed gastric emptying of the stomach after meals, often resulting in symptom flare-ups that include nausea, vomiting, abdominal pain and bloating. It occurs disproportionately in adult women.
In early trading, shares of Evoke fell from Monday’s closing price of $1.70 to 70 cents.
