GlaxoSmithKline's Phase IV obligations for its Commit nicotine polacrilex lozenge include a study of consumers who are contraindicated for use of the OTC smoking cessation drug due to underlying health conditions, FDA's Oct. 31 approval letter states.

GSK will conduct "a study...in subjects with relative contraindications for use (underlying diseases such as Diabetes mellitus or cardiovascular disease) who may be directed by their physician to use a nicotine product," FDA says in approving NDA 21-330.

FDA notes GSK submitted the protocol on Oct. 1 and will begin the study in May 2003. A final report should be filed by February 2004, the agency adds.

The firm also will conduct a study "to solicit adverse event information" related to Commit. The protocol for this study was submitted Sept. 13 and the research will begin next month, with a final report due in June 2003, FDA says.

The postmarketing study commitments differ from those required of other OTC nicotine-replacement therapy manufacturers. For example, in approving Novartis' Habitrol patch for OTC use in November 1999, FDA stipulated the company conduct safety surveillance to detect patterns of drug misuse/abuse.

Agency approvals for the NicoDerm CQ patch, Nicorette gum (both GSK) and the Nicotrol patch (formerly marketed by McNeil) required the sponsors to conduct studies on the safety and efficacy of the drugs in adolescents (¹ Also see "SmithKline's Nicoderm CQ will be second transdermal patch on market." - Pink Sheet, 5 August, 1996., p. 1 and ² Also see "SmithKline Beecham to conduct Phase IV Nicotrol safety/efficacy study in adolescents." - Pink Sheet, 15 July, 1996., p. 1).

FDA's approval letter for Commit says submission of pediatric studies for patients ages 10-17 is deferred until Oct. 31, 2007. However, the agency notes the pediatric rule, under which the studies would be required, is the subject of ongoing litigation.

The newest product to join the OTC smoking cessation category, Commit lozenges will hit food, drug and mass shelves later this month, GSK said.

The firm is highlighting Commit's unique lozenge delivery vehicle, as well as its "groundbreaking new dosage-selection tool," known as "time to first cigarette." TTFC "enables smokers to get the right strength of nicotine based on how quickly they need to smoke after waking," GSK said.

"With TTFC, those who smoke their first cigarette within 30 minutes of waking are directed to use the 4 mg strength" of Commit, while those who smoke their first cigarette after 30 minutes of waking are advised to use the 2 mg strength, the firm noted.

Commit "goes to work after you place it in your mouth, releasing nicotine as it dissolves to effectively reduce cravings," GSK said.

Product directions recommend a six-month regimen involving tapering of lozenge intake until the consumer is "completely nicotine-free." Individuals should take one lozenge every one to two hours for the first six weeks, one lozenge every two to four hours in weeks seven through nine and a lozenge every four to eight hours in weeks 10 through 12, the firm said.

The lozenge, which has a light mint flavor, will be available in 2 mg and 4 mg strengths for consumers 18 and older. A 72-count pack will retail for roughly $39.99, and a 168-count also will be available.

Commit will include "a comprehensive user's guide that explains the process of quitting, how the Commit lozenge works [and] the TTFC dosage method," GSK noted. Purchasers also will receive free enrollment in the Committed Quitters behavioral support program.

GSK will back the launch with an "extensive" advertising campaign, consumer and event promotions and PR initiatives, the firm said. TV and print ads, designed by Arnold McGrath Worldwide (New York), are slated to break in early December.

The ad effort will represent competition for Pharmacia's recently launched $50 mil. campaign in support of its Nicotrol Step-Down Patch (³ Also see "Nicotrol Step-Down Patch Supported By $50 Mil. Marketing Campaign" - Pink Sheet, 28 October, 2002., p. 6).

GSK's NRT lozenge has been well-received in the UK, where it was launched about a year ago under the brand name NiQuitin CQ .

The NDA for Commit was submitted to FDA in December 2000. Although the agency said marketing exclusivity for Commit has not yet been determined, GSK noted it will receive three years exclusivity under Hatch/Waxman.

Now that lozenges have received FDA approval as smoking cessation drugs, the agency could move to take action against Star Scientific's Ariva "cigalett," which the firm is marketing as a smokeless tobacco product. GSK and other petitioners have maintained the "cigalett" is a lozenge and should be regulated as either a food or a drug (⁴ Also see "Ariva “Cigalett” Pieces Are Foods, Not Smokeless Tobacco Items, GSK Says" - Pink Sheet, 4 March, 2002., p. 7).

GSK Commit Lozenge Phase IV Studies On Contraindications, AEs Planned

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