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Regulatory Focus™ > News Articles > 2019 > 9 > FDA’s OPDP Warns Insomnia Drugmaker Over Email

FDA’s OPDP Warns Insomnia Drugmaker Over Email

Posted 27 September 2019 | By Zachary Brennan 

FDA’s OPDP Warns Insomnia Drugmaker Over Email

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Atlanta-based Galt Pharmaceuticals for an email it sent that makes false or misleading claims related to its insomnia treatment Doral (quazepam), which FDA said are “extremely concerning from a public health perspective.”

The claims and presentation minimize the risks of abuse and dependence associated with Doral and suggest that the scheduled drug is superior in safety to other prescription and over-the-counter (OTC) products, OPDP said.

The agency also noted an algorithm used by the company that purportedly differentiates the likelihood of abuse and relative toxicity among 19 compounds, including Doral.

“However, as FDA pointed out in 2014, ‘the “algorithm” lacks actual abuse data in human subjects and has not been validated.’ While we acknowledge the figure includes the following statement, “*Please see complete prescribing information for detailed information on each product. The above chart is not intended for efficacy comparison. The authors algorithm, while comprehensive, does lack prospective abuse data in human subjects and had not been validated in subsequent research,” this statement does not mitigate the overwhelming impression that Doral is superior in safety to other prescription and OTC products,” FDA said.

OPDP also said that it expressed concerns regarding promotional materials for Doral in a previous letter in 2014  for the previous application holder for the drug. FDA said the other company, known as Sciecure, omitted important risk information, contained unsubstantiated superiority claims and omitted material facts.

The warning letter, which was released publicly on Thursday and sent two weeks ago, requests a response from Galt by Friday.

Warning Letter

Doral Email

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