Oral Film for Acute Migraine Treatment Closer to FDA Approval
Pharma companies developing a new delivery system for an existing Migraine treatment medication are one step closer to receiving FDA approval of it. The drug, currently called, RHB-103 is a dissolving oral film formulation of rizatriptan.
The companies developing RHB-103, RedHill Biopharma and IntelGenx, filed a New Drug Application (NDA) with the Food & Drug Administration (FDA) last year. The NDA was approved for review in June 2013.
The FDA issued a Complete Response Letter on February 4, 2014, that addresses the NDA for RHB-103. A Complete Response Letter is not an approval, but it's not a rejection, either. The FDA uses a Complete Response Letter to inform a company about issues still being considered and/or information needed to approve the product.
The FDA said no further studies of RHB-103 are needed because the bioequivalence and safety data is acceptable as submitted in the NDA. Bioequivalence means that two drugs with the same active ingredient are similarly bioavailable (the degree and rate at which a drug is absorbed and made available at the site of action) and produce the same effect at the site of action in the body. No issues were raised about RHB-103's safety.
But there are a few things remaining to be addressed before RHB-103 can be approved and hit the market. The FDA needs these applicants to address Chemistry, Manufacturing and Control (CMC) issues and product labeling. The applicants say they believe they can address these questions with existing information and plan to do so within a few weeks. CMC relates to the way the product is made and the controls in place for assuring quality in manufacturing.
RHB-103 utilizes IntelGenx's proprietary VersaFilm (TM) technology to provide quick delivery of rizatriptan, a 5-HT1 receptor agonist. The film dissolves quickly in the patient's mouth and is absorbed into the bloodstream through the gastrointestinal track. So while it is not necessary for the patient to have water on hand to use the medication or keep a pill down for any length of time, it will be susceptible to the same gastrointestinal slowing issues as existing pills and orally disintegrating tablets. To learn more about why this is a concern, please read: Migraine & Gastroparesis: Nausea, Vomiting & Diarrhea.
Maxalt has the same active ingredient as RHB-103, rizatriptan. Maxalt has been shown in clinical trials to be more effective than placebo and has been FDA approved for treatment of acute Migraine attacks for a number of years. Therefore, the success of clinical trials comparing the bioavailability of RHB-103 and Maxalt provides promising information about the efficacy of this new formulation for Migraine patients.
Have you checked out the new Community Hub yet?