FDA Declines Approval of Versafilm Migraine Treatment

Susan Jeffrey

February 04, 2014

The US Food and Drug Administration (FDA) declined approval for an oral thin-film formulation of rizatriptan (VersaFilm, IntelGenx and RedHill Biopharma) for the treatment of acute migraine, the companies announced today.

A Complete Response Letter (CRL) from the agency regarding their New Drug Application (NDA) for this product, a proprietary oral thin-film formulation of the 5HT1 receptor agonist rizatriptan (Maxalt, Merck & Co.), did not call for new trials, and issues were mainly related to third-party packaging and labeling.

"The questions raised by the FDA in the CRL regarding the NDA for the anti-migraine VersaFilm product primarily relate to third party Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labelling of the product," the companies note in a statement. "No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional studies."

The companies said they believe the requested information can be supplied on the basis of available data, and that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the agency "that has yet to be reviewed," the release adds. "The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks."

They have also been in active discussions with potential partners for commercialization of the product and plan to advance these talks rapidly after the increased "regulatory clarity" following the CRL.

"We appreciate the thorough review of the product NDA by the FDA. We remain committed to bringing the product to market as quickly as possible and will work closely with the FDA to advance the application and address all questions raised by the FDA," said Rajiv Khosla, president and CEO of IntelGenx, and Dror Ben-Asher, RedHill's CEO, in a joint statement.

"We believe that the questions raised by the FDA can be addressed based on available data, and we plan to work vigorously to submit our response within a few weeks in order to bring this product to market as a new therapeutic option for the benefit of patients suffering from migraines."

In addition to pursuing marketing approval in the United States, and following a positive meeting with the German pharmaceuticals regulation authority BfArM in October 2013, the companies plan to complete the development program for the European market and submit a Marketing Authorization Application for marketing approval of the product in Europe later this year, with Germany as the reference member state under the European mutual recognition procedure.

The product is based on the IntelGenx proprietary VersaFilm technology, which dissolves rapidly in the mouth, leading to the absorption of the drug through the gastrointestinal tract and into the bloodstream.

"The administration method of the oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea — approximately 80% of the total migraine patient population," the statement notes.

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