Smoking Cessation

October 22, 2012

Pfizer released results from a phase IV trial of Chantix/Champix (varenicline) for the treatment of smoking cessation. This double-blind, placebo-controlled, randomized study enrolled 525 smokers ages 19-73, with a past or present diagnosis of Major Depressive Disorder (MDD). Subjects received Chantix/Champix 1mg twice daily or placebo for 52 weeks. Results showed that subjects in the Chantix/Champix arm had a higher likelihood of quitting smoking at the end of the treatment period. The Continuous Quit Rate (CQR) between weeks 9 and 12 was 35.9% for Chantix/Champix versus 15.6% for placebo, and between weeks 9 and 52 was 20.3% versus 10.4%, respectively. The drug was well tolerated. The most frequent adverse events were nausea, headache, abnormal dreams, irritability and insomnia. Additionally, the most common neuropsychiatric adverse events were anxiety, agitation, depression, tension, depressed mood, sleep disorders, hostility and restlessness.

September 24, 2007

Nabi issued positive nine-month data from a phase IIb trial of NicVAX for the treatment of nicotine addiction and relapse. This double-blind, placebo-controlled, dose-ranging trial enrolled 301 heavy smokers who received placebo or two doses of NicVAX (200 mcg and 400 mcg per injection) and two different regimens of administration. The primary endpoint was eight weeks of continuous abstinence between weeks 19-26. At nine months, the continuous abstinence rate in the NicVAX 400 mcg arm was 18% versus 4% for placebo (p=0.0047) and in the NicVAX 200 mcg arm was 14% versus 4% for placebo (p=0.027). The most effective schedule was determined to be five injections over six months and the most effective dose was determined to be 400 mcg. In addition, there was no compensatory smoking or increase in withdrawal symptoms. Treatment continued to be well tolerated over nine months, with a safety and tolerability profile comparable to placebo. Based on the results, Nabi plans to continue with the development of NicVAX.

TorreyPines reported positive results from a phase I trial of NGX267 for the treatment of cognitive impairment associated with schizophrenia (CIAS). This double-blind, placebo-controlled study enrolled 60 healthy males in Belgium. The subjects were placed in sequential dosing cohorts to receive a single, oral dose of either 10, 20, 30 or 35 mg of NGX267 once daily for four consecutive days. The primary endpoint of safety was achieved. Treatment was well tolerated at doses up to and including 30 mg. A secondary endpoint was to obtain quantitative measures of salivary flow, taken prior to and at multiple points post-dosing. Results showed increases in peak and total salivary flow for NGX267 arms in comparison to placebo. These effects increased with dose and maintained over the four day treatment period. These subject peak increases in salivary flow correlated with peak plasma levels of NGX267. Based on the results, TorreyPines plans to initiate a phase II dose-ranging trial in the first half of 2008.

July 31, 2006

Somaxon announced positive results from a phase II trial of nalmefene for use as an aid in smoking cessation. This single center, randomized, placebo-controlled study enrolled 76 subjects, who received one of two doses of the drug (40mg or 80mg) or placebo. Trial data indicated that the 40 mg dose of the drug yielded numerically higher abstinence rates at all timepoints relative to placebo. Subjects receiving the higher nalmefene dose did not achieve numerically superior rates in abstinence relative to placebo. Safety data indicated that the drug was well tolerated, with the most commonly reported adverse events being transient insomnia and nausea.

March 7, 2005

Xenova Group reported 12-month results of a phase I trial of their vaccine TA-NIC, for the treatment of nicotine addiction. Study data yielded evidence of efficacy, with a greater incidence of quitting for both the low (19%, n=3) and higher dose (38%, n=6) cohorts vs. placebo (8%, n=1). Incidence of quitting attempts was also higher in the TA-NIC groups (95% vs. 73%). The study also yielded immunogenicity data, which reconfirmed the optimal dose of 250 µg. obtained in previously, and showed that a booster treatment at 32 weeks produced a significant, sustained increase in nicotine-specific antibodies. No serious safety or tolerability concerns were raised. This double-blind, placebo-controlled study enrolled 60 patients who smoked between 10 and 75 cigarettes per day, who were randomized 4:1 to receive one of three doses of TA-NIC (50 µg, 250 µg or 1000 µg) or placebo via intramuscular injection at weeks 0, 2, 4, 6, 8 and 12, with an additional booster at 32 weeks.

October 4, 2004

Nabi Biopharmaceuticals issued positive phase II results for NicVAX, their nicotine conjugate vaccine for the promotion of smoking cessation. Preliminary results demonstrated that the drug was significantly efficacious in helping smokers quit, with 33% of subjects on the highest dosing regimen ceasing cigarette use, compared to 9% of subjects who received placebo treatments. The vaccine also yielded a significant reduction in consumption and nicotine dependence among non-quitters at its highest dose, compared with placebo. NicVAX treatment was safe and well tolerated. This double-blind, placebo-controlled, randomized study enrolled a total of 68 smokers, who received up to 4 injections of one of three doses of the drug or placebo over 182 days. Smoking cessation was confirmed by serum cotinine and carbon monoxide levels, and subjects received NicVAX treatments in the absence of any other pharmacological or behavioral therapies. NicVAX announced plans to advance the drug to late stage testing in the near future.

July 19, 2004

Xenova Group announced positive initial results of the second phase I study of TA-NIC, their therapeutic vaccine for the treatment of nicotine addiction. Preliminary data showed the vaccine to be safe, well tolerated, and immunogenic at therapeutic doses, with no serious adverse events noted, only minimal incidence of injection site reactions at optimal dose levels, and a more rapid onset and greater magnitude of anti-nicotine antibody response than with doses used in earlier trials. The trial also found preliminary evidence of efficacy, including anecdotal reports of reduction in smoking pleasure or initiation of abstinence from tobacco use, with 43% of TA-NIC subjects reducing or ceasing smoking, compared with only 9% of the placebo group. The double blind, placebo-controlled trial randomized 60 smokers to receive one of two doses of TA-NIC or placebo. Based upon these results, Xenova announced plans to begin a phase II/III trial of the vaccine in the immediate future.

March 1, 2004

Nabi Biopharmaceuticals reported positive results from a phase I/II trial investigating NicVAX, a vaccine for the treatment of nicotine addiction. Results showed that NicVAX was well tolerated and was able to generate high levels of nicotine specific antibodies. Data showed that three doses of NicVAX produced antibodies, which declined slowly over several months. Common reactions were tenderness, aching and redness at the injection site. The most frequent systemic reactions were myalgia, headache and malaise. The double-blinded, placebo controlled study enrolled 30 smoking and non-smoking subjects over six months. Subjects were given a series of four injections containing either NicVAX or a placebo. Results were presented at the Annual Meeting of the Society for Research on Nicotine and Tobacco in Tucson, Arizona.