Cytisinicline treatment shows increased rate of vaping cessation: ORCA-V1 results
Click Here to Manage Email Alerts
Key takeaways:
- Cytisinicline vs. placebo doses in adults who used e-cigarettes resulted in greater chances of quitting.
- The drug was “very well tolerated” with a comparable number of adverse events to placebo.
In adults who currently use e-cigarettes, a heightened likelihood of quitting was found in those receiving cytisinicline for 12 weeks compared with placebo, according to topline results from the phase 2 ORCA-V1 trial.
“These results provide evidence that cytisinicline may be effective as a treatment of nicotine dependence, and not just to help people quit cigarettes,” Nancy Rigotti, MD, director of the Tobacco Research and Treatment Center at Massachusetts General Hospital and ORCA-V1 PI, told Healio.
In a randomized, placebo-controlled phase 2 trial, Rigotti and colleagues analyzed 160 adults (mean age, 34 years) who reported current use of nicotine e-cigarettes or vapes to determine if cytisinicline (Achieve Life Sciences) was safe and effective in helping these patients quit.
“Cytisinicline is being tested to help adults to quit smoking, and it has shown effectiveness for smoking cessation in a previous trial,” Rigotti told Healio.
For 12 weeks, the adults received either 3 mg of cytisinicline three times each day or placebo. Continuous abstinence from weeks 9 to 12 of treatment was the main outcome, according to a press release from Achieve Life Sciences.
Of the total cohort, 72% of adults used to smoke combustible cigarettes. The release also said that the median number of quit attempts from vaping in this patient population was two.
In the last 4 weeks of treatment, researchers observed that more patients receiving cytisinicline quit vaping than patients receiving placebo (31.8% vs. 15.1%), which suggests 2.6 times increased odds for cessation with the drug (P = .035), according to the release.
Similar results were found with evaluation into several demographics including age, gender, race and/or smoking history.
“In addition to people who smoke cigarettes, clinicians may be seeing people who are using e-cigarettes, either because they started as teenagers or because they switched to e-cigarettes from smoking,” Rigotti told Healio. “Many of these people want to quit e-cigarettes too and some need help, but we know little about how to help them. In the future, this might be a drug that clinicians can prescribe to help people who use e-cigarettes to quit.”
In terms of safety, the release reported that the drug was “very well tolerated” and had a comparable number of adverse events to placebo (50.9% vs. 54.7%), with no serious events.
Frequent adverse events experienced by both groups included anxiety, headache and upper respiratory tract infections. Those receiving cytisinicline also often reported sleep disturbance and fatigue, according to the release.
“If approved, cytisinicline would be the first smoking cessation medication approved in nearly 20 years, and clinicians would have a new medication to use when they try to help their patients who smoke to quit,” Rigotti said.
However, these results need validation in more current adults who use e-cigarettes, Rigotti added.
“A larger phase 3 study can provide stronger statistical confidence that the results found in the smaller study are correct,” she said. “It would also need to demonstrate that the effect lasts even after the medication ends.”
Rigotti further told Healio a notable takeaway from this study is the number of adults who use e-cigarettes that have the desire to quit.
“We were pleased to find out that those who use nicotine e-cigarette, who are on average several decades younger in age than those who smoke cigarettes, want to quit vaping and are willing to use a medication to help them succeed,” she said.
Phase 3 trial results of ORCA-3, which investigated cytisinicline in adults who currently smoked cigarettes with a desire to quit but were unsuccessful with available treatments, will be released in the second quarter of 2023, according to Rigotti.