GSK's oral nicotine spray wins divided FDA panel's backing despite abuse risks

GlaxoSmithKline's OTC nicotine spray will go up for approval with an advisory committee's split recommendation. (Pixabay)

With the federal spotlight on e-cigarette use, agencies such as the FDA have grown wary of nicotine-based products with risks of adolescent abuse. That didn’t stop GlaxoSmithKline from winning a recommendation for its over-the-counter nicotine spray—but the backing didn’t come easy.

An FDA advisory committee panel voted 9-6 to recommend GSK’s oral spray for approval for users 18 years and older, despite concerns the treatment could lead to elevated risks of abuse and addiction in nonsmokers, adolescents and children.

In remarks prepared for the panel Wednesday, Theresa Michele, the FDA’s division director of nonprescription drug products, said dependence was the most reported serious adverse effect for the spray. In one study, Michele said, 79% of subjects in the active treatment group continued to use the product after the treatment period ended at Week 26, even though only 3.4% had quit smoking, which suggested double use of the spray and tobacco products.


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.

“A question raised during review of the application is whether (the spray) is more likely to result in misuse or abuse, particularly by nonsmokers (including adolescents and children) and persons not trying to quit smoking,” she wrote. “While a few clear-cut cases of recreational use by adolescents resulting in adverse events were described, substantial numbers of cases were not.”

Despite those concerns, the panel gave its split approval to GSK, which already markets Nicorette OTC gum and prescription spray.

The increased scrutiny on the spray comes as federal regulators and the White House have locked down the distribution and sale of flavored vaping products, including e-cigarettes.

Last week, President Donald Trump said his administration was working on a ban for flavored e-cigarette products after hundreds of illnesses and at least six deaths were reportedly linked to their use.

In concert with the president’s ban, the FDA followed suit with an enforcement plan to keep “unauthorized, non-tobacco-flavored e-cigarette products” off the market. The details of the plan weren’t immediately made clear in the FDA’s release.

“The Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” HHS Secretary Alex Azar said in a statement.

The FDA, now under acting Commissioner Ned Sharpless and before that under Scott Gottlieb, has engaged in a yearslong battle to stave off the sale of flavored e-cigarettes to adolescents, including fielding a plan late last year to ban most of them from shelves.

In November, the FDA laid out a tentative proposal to ban the products from shelves—a move that followed the agency’s reworked enforcement framework to go after unauthorized products.

“The bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes,” Gottlieb said in a statement. “We won’t let this pool of kids, a pool of future potential smokers, of future disease and death, to continue to build.”