Clinical Trial Shows eNT Inhaler Produces Rapid and Significant Reductions in Smoking Urge Data Show Rapid Onset of Action Combined with Strong Preference for eNT's Device Versus Smoking
CHAPEL HILL, N.C., Feb. 14, 2014 /PRNewswire/ -- e-Nicotine Technology (eNT) announced details from its initial clinical trial that were presented last week at the 20th Annual Meeting of the Society for Research on Nicotine and Tobacco in Seattle, WA. The data were part of a presentation entitled "Achieving Rapid Smoking Urge Relief and Nicotine Pharmacokinetics Through the Manipulation of the Particle Size of a Condensation Aerosol of Nicotine and Propylene Glycol." The clinical trial tested eNT's proprietary nicotine delivery system in a group of 77 dependent smokers that had not set a goal to quit smoking. eNT's 50, 75, and 100 mcg nicotine dose groups all reported significant (p<.01) reductions in their median percent smoking urge (75%, 70%, and 83%, respectively) at 1-minute after dosing, which were sustained over time. Fully 75% of subjects reported that they would use the 50 mcg nicotine aerosol as a substitute for their smoking.
"Smoking continues to be one the most preventable causes of death in the world, annually claiming more than 480,000 American lives, and nearly 6 million lives globally. Nicotine itself is not a carcinogen, and as Professor Michael Russell observed back in 1976, 'People smoke for nicotine but they die from the tar.' eNT is bringing the science of respiratory drug delivery to the development of a clean nicotine delivery system. Our electronic nicotine delivery device combines rapid nicotine delivery with electronic e-health tools both to help facilitate smokers' transition from combustible tobacco, as well as to taper off of nicotine entirely if they chose. Our electronic controls can also help to prevent child access," said Dr. Michael Hufford, Chief Medical Officer at eNT.
"These data mark an important inflection for us as a company. Having achieved our goals in this clinical trial, we can now rapidly move forward to commercialize this technology," said Jeffrey Williams, President and CEO of eNT. "These results position us to advance our technology to help address the needs of the majority of smokers who want a safer way to obtain their nicotine."
This ascending, placebo- and vehicle-controlled, dose ranging Phase 1 study explored the tolerability, pharmacokinetics and pharmacodynamics of eNT's 1-3 micron condensation aerosol of nicotine and propylene glycol. The clinical trial recruited 77 smokers (averaging 21.2 cigarettes per day) and randomly assigned them to 7 cohorts (N=9-12) involving dosing with 10 inhalations in the following conditions: placebo (air only), vehicle (propylene glycol only), 25, 50 (both 2.5% and 5% nicotine solutions), 75 or 100 mcg of nicotine per inhalation. Subjects were housed in a Phase 1 research clinic overnight and nicotine deprived for at least 12 hours prior to dosing. Outcome measures included smoking urge (baseline, 1-, 15- and 30-minutes post-dosing), nicotine concentrations (baseline, 30-seconds, 5-minutes post-dosing), the modified Cigarette Evaluation Scale, and a product debriefing assessment. At baseline, subjects reported a strong smoking urge, averaging 75 on a 100-point scale. The placebo, vehicle, 25 and 50 mcg (5.0%) dose groups reported modest median percent smoking urge reductions (13%, 17%, 38%, and 39%, respectively) at 1-minute post-dosing. In contrast, as noted above, the 50 (2.5%), 75, and 100 mcg dose groups all reported significant (p<.01) reductions in their median percent smoking urge (75%, 70%, and 83%, respectively) at 1-minute post-dosing, which were sustained over time. The nicotine dosing groups produced median nicotine concentration changes between .68 and 2.0 ng/mL within 30 seconds after dosing. Additional analyses revealed that more dependent smokers reported greater smoking urge reductions than less dependent smokers, irrespective of their baseline smoking urge.
"These data are a critical catalysts for eNT. By leveraging the company's technical expertise, scientific data, strong intellectual property, and the Board's deep expertise in consumer products and commercial development, we're ideally poised to rapidly move into the commercialization phase for our product," said Rich Brenner of Life Science Angels, and member of eNT's Board of Directors.
About e-Nicotine Technology
eNT is a company committed to reducing the harms associated with tobacco products by combining clean nicotine aerosols for inhalation with empowering e-health tools. eNT is developing an electronic nicotine delivery device that produces a condensation aerosol of nicotine using its proprietary thermal drug delivery technology. The eNT platform delivers the right dose of nicotine using the right sized aerosol particles for deep lung delivery at the right time.
For more information about eNT, its technology, products, and other inquiries, please contact: Justin Bingham at +1.801.502.3458 or firstname.lastname@example.org, http://www.enicotinetechnology.com.
SOURCE e-Nicotine Technology