Regulatory authorization for nicotine inhaler

Regulatory authorization for nicotine inhaler

September 12, 2014

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted a product license for general sale to Kind Consumer’s Voke nicotine inhaler. The company will now submit a variation to the license to support full-scale commercialization by its commercial partner, Nicoventures.

“We are pleased to announce that the Voke Inhaler has been licensed in the U.K. as a medicinal product after a detailed review process by the MHRA,” says Chris Moyses, chief medical officer, Kind Consumer.

“It is a great achievement for the team to have successfully navigated the process to marketing authorization during which we have satisfied all questions raised by the MHRA. The technology contains no electronics, heat or combustion and will rival e-cigarettes and nicotine-replacement therapies when launched.”

Voke is licensed for use to relieve and/or prevent craving and nicotine-withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

The marketing authorization application comprised pharmaceutical, non-clinical and clinical data on the Voke Inhaler, including a clinical pharmacokinetic study comparing the Voke Inhaler with a commercially available pharmaceutical product. In addition, the Voke Inhaler includes a CE-marked medical device.

“It took over a decade to design and develop Voke, combining strict pharmaceutical safety standards while retaining the real consumer experience of the product,” says Alex Hearn, chief product officer, inventor of the technology and founder of Kind Consumer. “This invention, promises to make a real difference in offering smokers a safer alternative to smoking.”

“Achieving the first authorization for the Voke Inhaler as a licensed medicine is a major milestone for the company,” says Kind Consumer CEO Paul Triniman. “The Voke Inhaler will be commercialized by Nicoventures Ltd., now engaged in ensuring that automated manufacturing capacity will be in place, as well as the marketing plans to bring this advance in nicotine technology to smokers.”

Category: Breaking News

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