A British American Tobacco (BAT) subsidiary won approval from UK regulators to market a battery-powered nicotine inhaler similar to an e-cigarette as a Nicotine Replacement Therapy (NRT).
The Medicines and Healthcare products Regulatory Agency (MHRA) approved two variants of the e-Voke Electronic Inhaler in November, an agency document shows. Various British media said the approval marks the first one for an e-cigarette as medicine.
Applications filed for the inhaler, 10 mg and 15 mg, named as a reference product the Nicorette Inhalator licensed to McNeil Products. Other than a clinical study comparing blood nicotine levels in patients using e-Voke, Nicorette and cigarettes, no new non-clinical studies were conducted, “which is acceptable given that these are hybrid applications,” MHRA said.
E-Voke is a rechargeable stainless steel vaporiser in tube form that uses non-interchangeable cartridges containing pharmaceutical nicotine, water and glycerol. The MHRA product description makes no mention of flavouring, which is common to e-cigarettes sold on the general market. The marketing licenses were granted Nicoventures on 16 Nov, amended to Nicovations on 19 Nov.