FDA Sends Warning Letter to Drug Maker Over Claims in Sleeping Pill AdsNov 10, 2014
In an October 29 warning letter, the Food and Drug Administration (FDA) chastised drug maker Sciecure Pharma over claims made in its sleeping pill ads.
The FDA noted that in a four-page advertising spread for Doral, an insomnia medication, Sciecure Pharma asserted that Doral was superior to other sleep aids and cited studies to support this assertion, the Wall Street Journal blog Pharmalot reports.
The FDA Office of Prescription Drug Promotion objected to the studies cited in the ad, writing that the studies cited lacked “substantial evidence” to back the claims. “Two of the references cited are review articles which provide general descriptions of the pharmacodynamics, pharmacokinetics, and efficacy [of Doral] and other benzodiazepines, rather than descriptions of well-controlled clinical studies,” meaning that the studies did not explicitly support the notion that Doral is superior, according to the WSJ.
A third study offers an algorithm that “purportedly differentiates the likelihood of abuse and relative toxicity among 19 compounds,” including Doral. But the algorithm lacks actual abuse data in human subjects and was not validated. The FDA wrote that the fourth study lacked adequate statistical power and an appropriate patient population to draw any conclusions. The studies “do not describe adequate and well-controlled head-to-head clinical trials comparing appropriate doses” for Doral and comparable drugs in an appropriate patient population to support safety or efficacy claims, according to the WSJ. The studies do not constitute “substantial evidence” to support Doral as safer, or more effective, than other drugs for treating insomnia.
The FDA also criticized Sciecure for omitting risk information. Doral can cause withdrawal symptoms, severe anaphylactic reactions, changes in behavior or worsening depression, symptoms commonly associated with benzodiazepines, according to Regulatory Focus, newsletter of the Regulatory Affairs Professionals Society (RAPS).