Did Avanir overmarket its brain drug to the elderly?

Pills
Half of the Nuedexta pills Avanir has sold since 2012 ended up in long-term care facilities, a CNN investigation alleges.

California-based Avanir Pharmaceuticals isn’t quite a household name, with just two drugs on the market, but its ambitious marketing of one of those products is drawing headlines that are sure to be unwelcome. The latest comes courtesy of CNN, which alleges in a new investigation that Avanir inappropriately marketed its neurological treatment Nuedexta to nursing home residents.

Nuedexta is used to treat a rare condition called pseudobulbar affect (PBA), which is marked by sudden fits of laughing or crying.

CNN’s investigation reveals that sales of Nuedexta jumped 400% in four years to reach $300 million in 2016. The article alleges that half of the pills Avanir has sold since 2012 have gone to long-term care facilities. But the prescribing information that the company provides acknowledges the drug has not been extensively studied in elderly patients. And in one study of people with Alzheimer’s, it seemed to increase the risk of falling.

RELATED: Avanir shelves Danny Glover PBA awareness ad in favor of branded Nuedexta effort

What fueled the huge sales increase? The investigation uncovered examples of doctors who took payments from Avanir, a unit of Japan’s Otsuka Holdings, and prescribed Nuedexta to nursing home residents. One California psychiatrist, for example, received $500,000 in cash, travel and meals from Avanir and Otsuka in the three years ending in 2016, the story alleges. He was a speaker for the company and prescribed the drug to more than 100 patients in 11 long-term care facilities in 2012, the investigation found.

Avanir didn’t immediately respond to requests for comment from FiercePharma, however the company did publish a statement addressing the allegations. “PBA occurs in people who already have a neurological condition, such as ALS, MS, stroke, Alzheimer’s disease, other dementias or traumatic brain injury. Because neurological disorders commonly occur in residents of long-term care facilities, treatment with Nuedexta can be appropriate for residents in these facilities who also have PBA,” the company said. It added that its promotional activities comply with FDA policies and its own policies related to business conduct and ethics.

Maybe so, but this isn’t the first time Avanir’s marketing of Nuedexta has raised eyebrows. In 2016, the company ran extensive direct-to-consumer TV ads starring the actor Danny Glover that some critics charged were little more than an effort by the company to expand the audience for the drug to overly emotional (but otherwise healthy) people. The name of the drug didn’t appear in that ad.

Avanir pulled the Glover ads at the end of 2016 and replaced them with a branded campaign. “We’re shifting the focus and taking the awareness that campaign has built and building on it by turning the conversation to both PBA and treatment with Nuedexta,” Alana Darden, director of consumer marketing at Avanir, told FiercePharma at the time.

RELATED: Pharma groups to FDA: Stop that new off-label rule in its tracks

CNN’s investigation focuses less on Avanir’s public efforts to bring attention to Nuedexta and more on behind-the-scenes dealings with physicians and pharmacists who it allegedly paid to make presentations about the drug. One of those physicians is facing a government investigation on charges including accepting kickbacks, the news outlet found.

The Nuedexta saga also brings to light issues related to off-label marketing, a continuing controversy among pharma industry insiders—and their critics. Pharma companies have mostly prevailed in a recent string of off-label suits, but that didn’t stop the FDA from proposing a new rule on the subject in January. The proposed rule would have tightened up the definition of “intended use” of medical products in a way that could have restricted what life sciences companies say about off-label evidence.

But then Scott Gottlieb was appointed the new commissioner of the FDA, and the proposal seemed to stall. No surprise there: His boss, President Donald Trump, has given his appointees strict orders to pare down federal regulations.