RedHill Biopharma and IntelGenx issued a press release detailing the Food and Drug Administration’s (FDA) complete response letter to RHB-103, a drug for acute migraines. The federal agency required no further clinical studies as the drug’s efficacy and safety was accepted. However, the FDA found issues with manufacturing, packaging, and labeling. The drug’s sponsors intend to address the issues and respond to the FDA’s letter within weeks. The company also intends to pursue marketing rights in Europe.
RHB-103 is for the treatment of acute migraines. The migraine is a debilitating condition much worse than a common headache. Between 6 and 18% of people in the U.S. experience migraines on an intermittent or chronic basis. Work productivity and quality of life decreases for the person. Migraine medications vary in efficacy as individuals respond differently. Treatments include nonsteroidal anti-inflammatory drugs, acetaminophen, and aspirin. Physicians often prescribe triptans, dexamethasone, and lidocaine among others.
RHB-103 is a formula of rizatriptan benzoate, a 5-HT1 receptor agonist. One of the most effective triptans, rizatriptan constricts blood vessels in the brain, reducing swelling and pain. IntelGenx used its propriety VersaFilm technology to deliver RHB-103 in a thin film placed in the mouth. The film dissolves rapidly, dispersing the drug rapidly into the bloodstream through the gastrointestinal tract. The film delivery method is suited to migraine patients, as they often suffer from nausea and cannot tolerate taking pills or drinking liquids.
The FDA’s Response Letter
The FDA’s primary issue was in the intended manufacturing process, the packaging, and the labeling of the drug. The company states that it submitted recent documents responding to these issues that the FDA has yet to review. In any case, the drug’s sponsors plan to respond vigorously to the FDA’s concerns. The two companies are actively seeking partners in commercializing the drug. Rajiv Khosla, President and CEO of IntelGenx and Dror Ben-Asher, CEO of RedHill said in a joint statement, "We appreciate the thorough review of the RHB-103 NDA by the FDA. We remain committed to bringing RHB-103 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.”
Redhill is an Israeli biopharmaceutical specializing in late clinical-stage drugs. IntelGenx is a Canadian company working on oral drug delivery.