FDA Blasts Sleep Aid Advertisement as Misleading

The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral.

The sales aid omits various warnings, precautions and contraindications for Doral (quazepam), including abnormal thinking, withdrawal symptoms and depression, said an untitled letter. The aid also fails to disclose that patients shouldn’t drive the next day if the insomnia drug is taken with less than seven or eight hours of sleep.

The New Jersey drugmaker also omits various adverse reactions such as daytime drowsiness, headache, fatigue and dizziness and doesn’t say that it is indicated for a short period of time.
While the aid directs readers to the full prescribing information, this isn’t enough to balance out the lack of warnings, said the Oct. 29 letter.

The sales aid also misleadingly suggests Doral is safer and more effective than other insomnia treatments due to its unique mechanism of action. Sciecure says that Doral is the only benzodiazepine that provides BZ1 receptor selectivity, which doesn’t create the same drawbacks as typical benzodiazepines.

Sciecure lists four references, including review articles on the efficacy of quazepam and other benzodiazepines and articles citing general descriptions of pharmacodynamics and pharmacokinetics of quazepam. However, there are no references to well-controlled, head-to-head clinical trials comparing Doral to other products, which are necessary to make superiority claims, the FDA said.

Sciecure also did not submit the sales aid to the FDA’s Office of Prescription Drug Promotion (OPDP) for review as required by federal regulations.

The agency calls for Sciecure to stop disseminating the sales aid.

Sciecure received the ninth untitled letter issued this year by OPDP. That is behind 2013’s pace, with OPDP already issuing 15 untitled and warning letters to drugmakers by this time last year.

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