Tuesday, September 16, 2014

Kind Consumer gains MHRA authorisation for Voke® Inhaler as an inhaled nicotine formulation to be used as a smoking reduction or cessation aid

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Kind Consumer gains MHRA authorisation for Voke® Inhaler as an inhaled nicotine formulation to be used as a smoking reduction or cessation aid [Link]

  • Kind Consumer has announced receipt of a product license from the UK regulator, MHRA for its nicotine inhaler (Voke® Inhaler 0.45mg)
  • The company now intends to submit a variation to the license to support full-scale commercialization by Nicoventures
  • Voke® is licensed for use "to relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence and 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 MAA included PK data comparing  Voke® with GSK's Nicorette inhalator
  • These data have recently been reported and demonstrate higher early AUC and shorter Tmax with Voke®, as well as reduced craving

Comments:  Voke® is not an e-cigarette - the main differences are summarized below [source], and has beaten e-cigarettes to gain regulatory authorisation for smoking reduction/cessation.  This product is more similar to GSK's Nicorette Inhalator which has been approved for this indication, but with some key differences.  Voke® has been designed to better mimic the look and feel of a cigarette.  Perhaps importantly is the improved nicotine delivery system.  Voke® is a pressure based system, charged from a pressurized can.  The Nicorette inhalator is instead a passive device requiring air to be drawn over wadding containing a nicotine solution resulting in predominantly oromucosal absorption of nicotine in the gaseous state. Instead, Voke® produces a fine aerosol of a medicinal nicotine formulation for inhalation via a breath actuated valve. This is reflected in the distinct absorption profile suggestive of pulmonary absorption. This has two advantages, firstly very little nicotine is exhaled, mitigating regulatory concerns of passive exposure.  Moreover, the improved PK profile is important as slow absorption vs conventional cigarettes has been suggested to limit craving reduction with earlier nicotine replacement products.  This is reflected in the improved reduction of craving with Voke® vs Nicorette Inhalator.  One point of interest is that the device could also be developed for delivery of other inhaled pharmaceuticals. Of note Nicoventures,   Kind Consumer's commercial partner is as an independent company within the BAT group dedicated to smoking alternatives, distinct from nicotine formulations such as patches, gums and e-cigarettes. Nicoventures announced its UK launch in 2011.


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