The Food and Drug Administration (FDA) has issued a warning letter to drug maker Sciecure Pharma, chastising the company for insufficient evidence backing claims made in its sleeping pill ads.
The agency questioned the evidence backing the claims of superiority in a four-page advertising spread for the insomnia medication Doral (quazepam), and also criticized the company for omitting common adverse reactions to the medication. In the ad, Sciecure Pharma cited studies to support the claim of superiority. But the FDA Office of Prescription Drug Promotion said the studies referenced lacked “substantial evidence” to back the claims, the Wall Street Journal blog Pharmalot reports.
“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.” These studies did not explicitly support the notion that Doral is superior to other sleep medications, according to the WSJ.
A third study referenced in the ad spread offers an algorithm to differentiate the “likelihood of abuse and relative toxicity among 19 compounds,” including Doral. But the algorithm lacks actual abuse data in human subjects, the FDA said. The agency said the fourth study cited did not have an appropriate patient population to draw any conclusions. The studies did not present “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 support Sciecure’s claim that Doral is safer or more effective than other drugs for treating insomnia.
The FDA letter also criticized Sciecure for omitting risk information. According to Regulatory Focus, the newsletter of the Regulatory Affairs Professionals Society (RAPS), Doral can cause withdrawal symptoms, severe anaphylactic reactions, behavior changes, or worsening depression, symptoms commonly associated with benzodiazepines. “By omitting serious and common risks associated with the drug, the sales aid misleadingly suggests that Doral is safer than has been demonstrated,” according to the FDA.