IntelGenx (TSXV:IGX; OTCQX:IGXT) reported successful results from a bioequivalence study for RIZAPORT, its proprietary anti-migraine VersaFilm product, demonstrating that RIZAORT is bioequivalent to the U.S. reference drug, Maxalt-MTL, and the European reference, Maxalt-Lingua.
RIZAPORT is an oral thin-film formulation of rizatriptan for the treatment of acute migraines. It offers an innovative and potentially advantageous therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nausea, due to its convenient dosing, facile intake due to the lack of need for water, and neutral flavor.
The bioequivalence study is expected to support the submission of additional information related to the transfer of manufacturing to IntelGenx’s GMP compliant site required by the FDA to allow for a full review of the company’s 505(b)(2) NDA resubmission for RIZAPORT.
The study will also be used to support applications to transfer the manufacturing of RIZAPORT from the European contract manufacturer listed in the initial application to IntelGenx’s site. It also will be used to support applications in additional European countries.
“This successful bioequivalence study helps pave the way for RIZAPORT, once approved, to be the first commercialized VersaFilm product to be manufactured at our new state-of-the-art facility,” Dr. Horst Zerbe, president and CEO of IntelGenx, said in a statement.
Several years ago, IntelGenx made a strategic decision to transform itself from a development company that relied on royalty and license revenues from a limited product portfolio into a full-service, global leader of innovative pharmaceutical oral film development and manufacturing.
“While that decision temporarily impacted on the company’s profitability due to the need to make significant new investments in plant and people, we firmly believed that we had an opportunity to build a much stronger business – one able to drive significant and sustainable growth over both the mid- and long-terms,” Dr. Zerbe said.
“In many ways, anticipated approvals to manufacture RIZAPORT at IntelGenx’s site will serve to help validate that choice,” he added.
