- The Food and Drug Administration has raised a red flag regarding a marketing video Supernus Pharmaceuticals submitted to the agency for its drug Oxtellar XR.
- In a warning letter dated Oct. 31 and released last week, the FDA targeted risk claims in the video that were "false or misleading." In particular, the agency took issue with statements from pediatric neurologist Jesus Eric Piña-Garza that suggested Oxtellar XR could be used to treat epilepsy.
- The drug in question is an adjunctive medicine aimed to treat partial epilepsy. As such, the FDA requested Supernus stop distributing the video. A response letter detailing whether the company will follow the agency's guidance, as well as a plan to remove the offending materials was due on Nov. 14.
"We acknowledge that the correct indication appears following his presentation in scrolling text and a voiceover; however, placement of the indication following Dr. Piña-Garza’s presentation does not negate the earlier statements," the FDA said in the warning letter.
In addition, the agency faulted Supernus for not giving adequate highlight to the health risks associated with Oxtellar XR, which range from headache and fatigue to hyponatremia, anaphylactic reactions and organ hypersensitivity.
"The presentation in the video is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug," the FDA said.
With just two products on the market, Supernus seems likely to comply with the agency. In the third quarter, Oxtellar XR brought in $13.9 million, representing nearly 25% of total sales and a 60% jump from the revenue it generated during the same period in 2015.
Outside of marketing efforts, Supernus has been busy defending Oxtellar RX from generic competitors. The company revealed in a second quarter financial filing with the Securities and Exchange commission that it filed claims for intellectual property infringement with several third-party organizations.