Trial Shows Weight Loss Drug Can Help Stop Smoking

(National Institute of Mental Health)

3 November 2014. First results from an intermediate-stage clinical trial shows lorcaserin HCl, a drug approved to help people lose weight, also helps regular smokers stop smoking. The findings were reported today by Eisai Inc. and Arena Pharmaceuticals Inc., who offer lorcaserin HCl under the brand name Belviq. The companies say more results will be reported at a future scientific meeting.

Lorcaserin HCl, or lorcaserin hydrochloride, is a chemical that binds to and activates serotonin 2C receptors in the brain. Serotonin is a neurotransmitter, a chemical regulating signals between neurons or nerve cells, in this case a key reward pathway affecting mood, pleasure, and memory, influencing an individual’s responses to food, sex, and social interaction.

Arena developed lorcaserin HCl as a drug to help obese and overweight patients lose weight, in conjunction with changes in diet and exercise. Lorcaserin HCl is a 10 milligram tablet that targets a hunger receptor in the brain, so individuals taking the drug feel satisfied while eating less, although the drug’s precise mechanism to achieve this result is not yet known. After approval by FDA as a weight-control drug in 2012, Arena enlisted Eisai for its distribution and marketing beginning in June 2013.

The clinical trial, conducted by Arena, enrolled 603 adult participants at 31 sites in the U.S., who smoked 10 or more cigarettes a day. The study randomly assigned participants to receive either lorcaserin HCl twice a day, once a day, or a placebo for 12 weeks. The primary end-point or objective of the study was complete abstinence from smoking for the last 4 weeks, 9 through 12.

Results show 15 percent participants taking lorcaserin HCl twice a day are able to achieve complete abstinence for the last 4 weeks, compared to 9 percent for participants taking the drug once a day, and 6 percent for those receiving the placebo. The difference in quit rate between twice a day and placebo participants is large enough to be statistically reliable.

The study also has a number of secondary measures related to smoking and eating behavior. The companies reported only differences in weight, which show participants taking the drug twice a day losing 0.98 kilograms (2.2 lbs), compared to the placebo participants who losing 0.01 kilograms (0.02 lbs).  Adverse effects reported by participants include headache, nausea, constipation, dizziness, and dry mouth, which the companies say are similar to previous trials of lorcaserin HCl.

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