Achieve Life Sciences Expects to File New Drug Application in US for Smoking Cessation Medication

MT Newswires Live
04-22

Achieve Life Sciences (ACHV) said it plans to file a new drug application with the US Food and Drug Administration in June for its cytisinicline drug candidate after publishing complete results on Monday from a second late-stage study again demonstrating it helped adult smokers quit by reducing their cravings for nicotine.

The phase 3 results, published Monday in the Journal of the American Medical Association, again show cytisinicline significantly increases the odds a smoker will quit compared to those treated with placebo, leading to decreased nicotine intake by binding to specific nicotine receptors and suppressing nicotine cravings.

Cytisinicline also was well tolerated throughout the 24-week trial, the researchers said, showing limited binding to other receptors in the brain that can cause adverse side effects such as nausea and other gastrointestinal disturbances.

The 792 participants in the second late-stage trial had a similar profile as those in the original phase 3 study, with an average age of 53 years old and who had smoked a median 20 cigarettes per day and who had tried to quit four times over a median 36 years of smoking.

Participants were split into groups receiving 3 milligrams of cytisinicline three times a day for either six or 12 weeks and monitored for a total of 24 weeks. The primary endpoint was biochemically verified abstinence rate during the final four weeks of treatment, the company said.

Shares of Achieve Life Sciences were 2% higher in recent trading.

Price: 2.03, Change: +0.04, Percent Change: +2.01

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