UPDATED: With FDA confab looming, Chantix experts can't persuade court to unseal Pfizer records

Next month, the FDA's expert advisers will take another look at Pfizer's ($PFE) stop-smoking drug Chantix. The official agenda: Weigh new data on Chantix's links to psychiatric side effects, and consider changing the black-box warning about those risks.

A couple of researchers want to be part of that meeting--and they wanted to bring some sealed court documents with them. Dr. Joseph Glenmullen and Thomas Moore--experts involved in litigation over Chantix's potential to trigger depression, suicide and violence--called on a judge to open up thousands of Pfizer documents related to those lawsuits.

The documents are "important to the public health," particularly because of the upcoming meeting on Oct. 16, the motion states. So, they should be unsealed "to provide ... a fair and balanced scientific record about the risks of varenicline, document what the company knew about those risks, and the actions it took."

The judge presiding over the last of that Chantix litigation didn't buy the argument. A Pfizer spokesman told FiercePharma that the motion has been denied.

Pfizer has its own arguments to make at the committee meeting. According to the FDA AdComm agenda, the committee will be looking at data from observational studies and a meta-analysis of controlled trials conducted after the original side-effects reports emerged. Among them could be a follow-up study Pfizer conducted in patients with depression, which found no difference in psychiatric problems between the Chantix arm and the control arm.

Chantix came under fire soon after its 2006 launch, as reports of suicidal depression, intense anger, and other psychiatric troubles surfaced. The drug briefly turned notorious when a semi-famous Dallas musician and Chantix user, Carter Albrecht, went into an angry fit and was shot and killed by his neighbor. Thousands of side-effect reports rolled in after the news aired. A U.S. soldier blamed Chantix for his sudden, brutal stabbing of a fellow recruit at Fort Benning, GA, but a jury didn't buy the argument; he was sentenced to life in prison.

After a review of the side effects reports and other data, the FDA added a black-box warning about psychiatric side effects back in 2009, including hostility, agitation, depressed mood, and suicidal thoughts or actions.

Naturally, the scandalous headlines didn't help sales. Before the side effects reports started rolling in, Chantix was churning out sales; in fact, until Vertex Pharmaceuticals' ($VRTX) hep C drug Incivek hit the market, Chantix was the industry's fastest launch. But by last year, sales had dropped by $648 million, down slightly from 2013--and from $846 million in 2008. The company cited the "lingering impact of negative media attention" for the slide.

Last year, Pfizer paid more than $275 million to settle thousands of lawsuits alleging that Chantix triggered suicides, suicidal thoughts and other psychiatric problems. The company says it stands by the drug and its risk-benefits profile. In late 2011, based on new study data, the FDA said that the drug doesn't appear to increase the risk of psychiatric hospitalization. But at the time, the agency affirmed that the black-box warning was still necessary.

Meanwhile, Pfizer has been working on a large clinical trial focused on Chantix safety. According to the FDA, the trial is designed to assess the drug's neuropsychiatric side effects. Results are expected in 2017. And the company still has hopes for goosing Chantix sales. According to Advertising Age, the company spent $90 million on Chantix advertising last year.

- read the experts' motion (PDF)
- get the story in the National Law Journal
- see the FDA meeting agenda

Special Report: Top 10 Drug Advertising Spends--Q1 2012 - Chantix

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