The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent its first untitled letter of 2017 to Orexigen Therapeutics for a television advertisement that created a misleading impression about the safety of the weight loss drug Contrave (naltrexone HCl and bupropion HCl).
OPDP found the ad, which opens with groups of women simulating a brain, contained efficacy claims for Contrave, but failed to include important risk information.
"For example, the TV ad includes the statement 'Do not take with opioids,' but fails to include any of the other conditions for which Contrave is contraindicated. Additionally, the TV ad includes the statement, 'CONTRAVE may increase suicidal thoughts or actions in some children, teens, and young adults within the first few months,' but fails to disclose any information about neuropsychiatric reactions also discussed in the BOXED WARNING section of the PI for Contrave … By omitting serious risks associated with Contrave, the TV ad misleadingly suggests that Contrave is safer than has been demonstrated."
Rejected by FDA in 2011 over concerns with side effects of the obesity drug, Contrave was later approved in 2014 and is a combination of two generic drugs in an extended-release formulation. In March 2016, Takeda handed over all of the drug's US marketing rights to Orexigen amid declining sales.
In the untitled letter, FDA also took issue with the misleading nature of communicating important risk information in the visual portion of the TV ad only, without risk information in the audio.
"For example, the TV ad discloses important risk information regarding the warning and precaution for the potential risk of hypoglycemia in patients with type 2 diabetes only as a SUPER [superimposed text over the image]," FDA added. "The overall effect of disclosing important risk information in SUPERs only, along with the simultaneous presentation of SUPERs and competing audio messages, undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Contrave."
Peter Flynn, SVP, Global Head of Development of Regulatory Affairs
and Safety at Orexigen, told Focus in a statement: "OPDP focused on the clarity of the safety
information included in the Contrave TV advertisement. Orexigen is currently
addressing the guidance provided in the OPDP letter. We are confident we will
be able to resolve the presentation of safety information in the TV
advertisement in a timely manner and respond to OPDP by the requested date of
The first letter of the year from OPDP comes as the office has sent a declining number of letters to biopharmaceutical companies over misleading advertisements, from 156 in 1998, to just 11 untitled and warning letters in 2016 and nine in 2015.
Orexigen Therapeutics, Inc. (Contrave) Untitled Letter 5/18/2017
Article updated with Orexigen comment.