FDA Cites Two Pharma Companies for Failing to Present Risks of Insomnia Drug

It’s been a slow year for the FDA’s Office of Prescription Drug Promotion (OPDP), with the regulator issuing just three violation letters for the 2017 calendar year. The agency’s latest warning letter was sent out to Amherst Pharmaceuticals and Magna Pharmaceuticals after they were found to have made “false or misleading” claims for their insomnia drug, Zolpimist.

The FDA asserts that the pharma companies failed to convey any risk information for Zolpimist on the product’s website, as well as at a booth at the SLEEP 2017 Annual Meeting of the Associated Professional Sleep Societies. The companies also made claims of superiority over other sleep aids, which were not supported by clinical evidence.

“These violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Zolpimist,” said the OPDP letter.

The regulator states that the companies did not submit a required form to the FDA before they began marketing the drug. The letter goes on to point out that Amherst and Magna made misleading claims about the onset of action for Zolpimist.

“In addition, the claim that Zolpimist ‘induces sleep’ in 10 minutes misleadingly suggests that the established therapeutic onset of action (i.e., time it takes patients to fall asleep) of Zolpimist is 10 minutes. Again, no references are cited to support this claim. FDA is also not aware of data to support this claim.”

Zolpimist is an oral spray that was acquired by Amherst in 2014 from NovaDel Pharma. Amherst partnered with Magna in 2015 to market the insomnia treatment.

The FDA’s OPDP concludes the letter by requesting that the pharma companies stop misbranding Zolpimist immediately, and submit a response letter to the regulator before November 29, 2017. With only five weeks to go before the end of 2017, this could be the last warning letter issued by the OPDP this year.