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This story has been updated.
The FDA’s Office of Prescription Drug Promotion issued its first untiled letter of 2017, telling Orexigen Therapeutics that its DTC ad for weight-loss drug Contrave failed to include appropriate risk information.
The ad, called “Your Brain,” cites some risks but not all of them. For example, it warns viewers not to take opioids while taking the drug, but does not list any other condition for which the drug is contraindicated. The company said in a statement that it is addressing the OPDP’s guidance.
“We note that the TV ad includes the statements, ‘Contrave is not for everyone’ and ‘Other side effects may occur,’” the FDA said in the May 18 letter. “However, this does not mitigate the omission of these important risks from the TV ad.”
The regulator also took issue with how the risk information was presented. Some of the risks were shared visually, while “unrelated” risk information was cited in audio messages that ran concurrently.
“Doing this undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Contrave,” the FDA said.
The regulator first approved Contrave in 2014 as a weight-loss treatment. Takeda Pharmaceutical Company had already signed on as a marketing partner, but the deal soured as prescriptions failed to take off among patients. Orexigen acquired back the U.S. rights from Takeda in March 2016 and has since invested in building a commercial organization that included the launch of the DTC ad in December.
Ad spending on Contrave nearly tripled from $1.2 million in 2015 to $3.5 million in 2016, according to Kantar Media.
“By year’s end, the stage has been set for us to implement the second phase of our relaunch, which we expect to drive significant growth in 2017 and beyond,” Mike Narachi, Orexigen’s president and CEO, told investors in March. “And that second phase was the introduction of a novel patient-centered campaign with DTC advertising.”
The untitled letter is the first one issued by the FDA’s Office of Prescription Drug Promotion in 2017. By this time last year, the regulator had issued three warning and untitled letters about promotional activities conducted by drugmakers.
CORRECTION: An earlier version of this article incorrectly described the letter. It is an untitled letter.