The U.K.'s harm reduction indication for a nonprescription nicotine replacement therapy inhaler could bode well for GlaxoSmithKline's request that FDA allow a similar change for NRT products in the U.S.
The U.K. Medicines and Healthcare products Regulatory Agency in December approved an application for an indication to include harm reduction among indications for Nicorette Inhalator, which Johnson & Johnson markets in the country and which is available in general sales.
NRT products available in U.K. general sales - similar to OTC access in the U.S. - also include gums, patches, tablets, lozenges and nasal sprays.
The MHRA's Commission on Human Medicines' Working Group assessed the harm reduction element for NicoretteInhalator and the possibility of the expanded indication in other NRTs. In addition to recommending approval for the Nicorette inhaler's indication, the commission suggested harm reduction is appropriate for other NRT forms, according to a Feb. 1 MHRA release.
MHRA on Dec. 11 granted the indication to J&J and said other NRT products also can use the indication. "Other companies wishing to incorporate this indication to their currently licensed NRT products are invited to do so," an agency official said in an e-mail.
GSK "Encouraged" By MHRA Move
A spokeswoman for GSK, which markets the Nicorette line and other NRT products in the U.S., says the firm "is encouraged by this latest development," although it does not expect the U.K. change to have an immediate impact on indications allowed for NRTs in the U.S.
Glaxo "recognizes and respects the differences in the regulatory processes of the U.S. and the U.K.," the spokeswoman said in an e-mail.
GSK's Consumer Health Division asked FDA in a Nov. 30 letter to consider updating NRT indications and warnings to allow for longer duration of use, as well as use prior to the actual quit attempt and use of multiple NRT types concomitantly, to maximize the public health benefit of using the products (1 'The Tan Sheet' Dec. 7, 2009).
The firm argues that current indication limitations for NRTs and the required warnings do not reflect science and may not allow for the best use of the products. GSK says it specifically will continue exploring more options and approaches to help adults quit smoking.
FDA Will Note U.K. Change
Some experts say the chances that the MHRA's decision will influence FDA appear stronger.
David Clissold, a food and drug attorney with Hyman, Phelps and McNamara, said the MHRA decision could lead the U.S. in the same direction.
"It's something the NRT makers here can point to in order to get the broader indications suggested by Congress in the law, but obviously doesn't bind FDA," said Clissold.
The Family Smoking Prevention and Tobacco Control Act passed in 2009 requires FDA to regulate tobacco products, including addressing the question of whether to expand use and indications for NRTs and other smoking cessation tools.
It also asks that the agency consider specifically indications for "craving relief" or "relapse prevention" when assessing applications for the products (2 'The Tan Sheet' Sept. 7, 2009).
Clissold pointed out that MHRA's inclusion of the harm reduction indication for NRTs could be applied to other smoking cessation products.
"MHRA is recognizing that a reduction in smoking reduces risk, and that is a good thing for the public health," he said.
NRT Indications Change Over Time
A public assessment report by MHRA notes that since 2005, NRT therapy has been recognized for use "to cut down smoking as a 'stepping stone' to quitting completely for smokers unable to stop abruptly."
The broader indications for the Nicorette inhalator include it will help a smoker "reduce smoking, with no limit on the treatment duration, with the aim of quitting when they are ready," MHRA says in its assessment.
The indications also include helping smokers "quit (abruptly stop)," "temporarily avoid smoking in front of others, so minimizing the risks associated with passive smoking" and "reduce compensatory smoking (smoking more intensely and/or using higher nicotine content cigarettes) after forced abstinence (e.g. in smoke-free environments, during hospitalization)," the report says.
The CHM Working Group advised language for the J&J NRT product information include, "Nicorette Inhalator relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke and as a safer alternative to smoking for smokers and those around them."
[Editor's note: Read more about this topic in 3 'The Tan Sheet,' your source for nonprescription pharmaceutical and nutritional industry news. For more information call 1-800-332-2181.]
- Katie Stevenson (4 k.stevenson@elsevier.com)
